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NCT00864097

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

Terminated Phase 3 Results posted Last updated 26 February 2021
What this trial tests

Phase 3 trial testing tanezumab in Osteoarthritis in 607 participants. Terminated before completion.

Timeline
11 August 2009
Primary endpoint
16 November 2010
24 November 2010

Quick facts

Lead sponsorPfizer
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment607
Start date11 August 2009
Primary completion16 November 2010
Estimated completion24 November 2010
Sites77 locations across France, Russia, Ukraine, Austria, Sweden, United Kingdom, Germany, Poland

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Primary · Baseline, Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale

Baseline
GroupValue95% CI
Placebo + Diclofenac6.06± 1.23
Tanezumab 2.5 mg + Diclofenac5.78± 1.36
Tanezumab 5 mg + Diclofenac5.76± 1.32
Tanezumab 10 mg + Diclofenac5.87± 1.30
Change at Week 16
GroupValue95% CI
Placebo + Diclofenac-1.91± 1.90
Tanezumab 2.5 mg + Diclofenac-2.18± 1.90
Tanezumab 5 mg + Diclofenac-2.28± 1.99
Tanezumab 10 mg + Diclofenac-2.42± 2.09
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Primary · Baseline, Week 16

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale sc

Baseline
GroupValue95% CI
Placebo + Diclofenac6.24± 1.45
Tanezumab 2.5 mg + Diclofenac5.86± 1.51
Tanezumab 5 mg + Diclofenac5.90± 1.22
Tanezumab 10 mg + Diclofenac5.91± 1.36
Change at Week 16
GroupValue95% CI
Placebo + Diclofenac-1.76± 1.78
Tanezumab 2.5 mg + Diclofenac-2.11± 1.99
Tanezumab 5 mg + Diclofenac-2.23± 1.99
Tanezumab 10 mg + Diclofenac-2.35± 2.07
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16 Primary · Baseline, Week 16

Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Hig

Baseline
GroupValue95% CI
Placebo + Diclofenac3.39± 0.57
Tanezumab 2.5 mg + Diclofenac3.28± 0.46
Tanezumab 5 mg + Diclofenac3.43± 0.56
Tanezumab 10 mg + Diclofenac3.37± 0.55
Change at Week 16
GroupValue95% CI
Placebo + Diclofenac-0.41± 0.70
Tanezumab 2.5 mg + Diclofenac-0.49± 0.74
Tanezumab 5 mg + Diclofenac-0.61± 0.83
Tanezumab 10 mg + Diclofenac-0.63± 0.87
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24 Secondary · Baseline, Weeks 2, 4, 8, 12, and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pa

Change at Week 2
GroupValue95% CI
Placebo + Diclofenac-1.30± 1.43
Tanezumab 2.5 mg + Diclofenac-1.22± 1.52
Tanezumab 5 mg + Diclofenac-1.21± 1.67
Tanezumab 10 mg + Diclofenac-0.86± 1.57
Change at Week 4
GroupValue95% CI
Placebo + Diclofenac-1.51± 1.55
Tanezumab 2.5 mg + Diclofenac-1.76± 1.65
Tanezumab 5 mg + Diclofenac-2.12± 1.70
Tanezumab 10 mg + Diclofenac-1.93± 1.71
Change at Week 8
GroupValue95% CI
Placebo + Diclofenac-1.63± 1.54
Tanezumab 2.5 mg + Diclofenac-1.88± 1.68
Tanezumab 5 mg + Diclofenac-2.22± 1.92
Tanezumab 10 mg + Diclofenac-2.34± 1.92
Change at Week 12
GroupValue95% CI
Placebo + Diclofenac-1.81± 1.59
Tanezumab 2.5 mg + Diclofenac-2.23± 1.82
Tanezumab 5 mg + Diclofenac-2.50± 2.03
Tanezumab 10 mg + Diclofenac-2.42± 2.00
Change at Week 24
GroupValue95% CI
Placebo + Diclofenac-1.81± 1.91
Tanezumab 2.5 mg + Diclofenac-2.11± 2.08
Tanezumab 5 mg + Diclofenac-2.24± 2.23
Tanezumab 10 mg + Diclofenac-2.19± 2.16
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 24 Secondary · Baseline, Weeks 2, 4, 8, 12, and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale sc

Change at Week 2
GroupValue95% CI
Placebo + Diclofenac-1.31± 1.42
Tanezumab 2.5 mg + Diclofenac-1.18± 1.45
Tanezumab 5 mg + Diclofenac-1.30± 1.57
Tanezumab 10 mg + Diclofenac-1.06± 1.40
Change at Week 4
GroupValue95% CI
Placebo + Diclofenac-1.46± 1.49
Tanezumab 2.5 mg + Diclofenac-1.58± 1.71
Tanezumab 5 mg + Diclofenac-2.09± 1.84
Tanezumab 10 mg + Diclofenac-1.81± 1.68
Change at Week 8
GroupValue95% CI
Placebo + Diclofenac-1.59± 1.52
Tanezumab 2.5 mg + Diclofenac-1.76± 1.72
Tanezumab 5 mg + Diclofenac-2.22± 1.88
Tanezumab 10 mg + Diclofenac-2.13± 1.91
Change at Week 12
GroupValue95% CI
Placebo + Diclofenac-1.75± 1.60
Tanezumab 2.5 mg + Diclofenac-2.13± 1.87
Tanezumab 5 mg + Diclofenac-2.43± 2.01
Tanezumab 10 mg + Diclofenac-2.28± 1.93
Change at Week 24
GroupValue95% CI
Placebo + Diclofenac-1.70± 1.86
Tanezumab 2.5 mg + Diclofenac-1.99± 2.13
Tanezumab 5 mg + Diclofenac-2.17± 2.19
Tanezumab 10 mg + Diclofenac-2.08± 2.21
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24 Secondary · Baseline, Weeks 2, 4, 8, 12, and 24

Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Hig

Change at Week 2
GroupValue95% CI
Placebo + Diclofenac-0.36± 0.79
Tanezumab 2.5 mg + Diclofenac-0.37± 0.65
Tanezumab 5 mg + Diclofenac-0.40± 0.68
Tanezumab 10 mg + Diclofenac-0.28± 0.71
Change at Week 4
GroupValue95% CI
Placebo + Diclofenac-0.40± 0.74
Tanezumab 2.5 mg + Diclofenac-0.45± 0.63
Tanezumab 5 mg + Diclofenac-0.65± 0.82
Tanezumab 10 mg + Diclofenac-0.54± 0.75
Change at Week 8
GroupValue95% CI
Placebo + Diclofenac-0.37± 0.72
Tanezumab 2.5 mg + Diclofenac-0.44± 0.70
Tanezumab 5 mg + Diclofenac-0.71± 0.85
Tanezumab 10 mg + Diclofenac-0.66± 0.79
Change at Week 12
GroupValue95% CI
Placebo + Diclofenac-0.45± 0.80
Tanezumab 2.5 mg + Diclofenac-0.52± 0.71
Tanezumab 5 mg + Diclofenac-0.69± 0.78
Tanezumab 10 mg + Diclofenac-0.61± 0.76
Change at Week 24
GroupValue95% CI
Placebo + Diclofenac-0.45± 0.77
Tanezumab 2.5 mg + Diclofenac-0.46± 0.76
Tanezumab 5 mg + Diclofenac-0.57± 0.86
Tanezumab 10 mg + Diclofenac-0.57± 0.91
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF Secondary · Weeks 2, 4, 8, 12, 16, and 24

OMERACT-OARSI responder: participant has \>=50 percent (%) change and \>=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: \>=20% change and \>=1 absolute change from Baseline in WOMAC pain subscale; \>=20% change and \>=1 absolute change from Baseline in the WOMAC physical function subscale; \>=20% change and \>=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor.

Week 2
GroupValue95% CI
Placebo + Diclofenac44.7
Tanezumab 2.5 mg + Diclofenac37.2
Tanezumab 5 mg + Diclofenac43.3
Tanezumab 10 mg + Diclofenac34.5
Week 4
GroupValue95% CI
Placebo + Diclofenac51.3
Tanezumab 2.5 mg + Diclofenac57.1
Tanezumab 5 mg + Diclofenac65.3
Tanezumab 10 mg + Diclofenac59.3
Week 8
GroupValue95% CI
Placebo + Diclofenac57.2
Tanezumab 2.5 mg + Diclofenac58.3
Tanezumab 5 mg + Diclofenac68.0
Tanezumab 10 mg + Diclofenac69.7
Week 12
GroupValue95% CI
Placebo + Diclofenac60.5
Tanezumab 2.5 mg + Diclofenac67.3
Tanezumab 5 mg + Diclofenac73.3
Tanezumab 10 mg + Diclofenac73.1
Week 16
GroupValue95% CI
Placebo + Diclofenac57.9
Tanezumab 2.5 mg + Diclofenac66.7
Tanezumab 5 mg + Diclofenac66.7
Tanezumab 10 mg + Diclofenac72.4
Week 24
GroupValue95% CI
Placebo + Diclofenac55.3
Tanezumab 2.5 mg + Diclofenac65.4
Tanezumab 5 mg + Diclofenac64.7
Tanezumab 10 mg + Diclofenac67.6
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 and 24 Secondary · Baseline, Week 16 and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale

Week 16: Greater than 0% reduction
GroupValue95% CI
Placebo + Diclofenac84.2
Tanezumab 2.5 mg + Diclofenac88.5
Tanezumab 5 mg + Diclofenac88.7
Tanezumab 10 mg + Diclofenac84.1
Week 16: >=10% reduction
GroupValue95% CI
Placebo + Diclofenac73.7
Tanezumab 2.5 mg + Diclofenac82.7
Tanezumab 5 mg + Diclofenac76.7
Tanezumab 10 mg + Diclofenac77.9
Week 16: >=20% reduction
GroupValue95% CI
Placebo + Diclofenac61.8
Tanezumab 2.5 mg + Diclofenac69.9
Tanezumab 5 mg + Diclofenac68.7
Tanezumab 10 mg + Diclofenac75.2
Week 16: >=30% reduction
GroupValue95% CI
Placebo + Diclofenac50.0
Tanezumab 2.5 mg + Diclofenac54.5
Tanezumab 5 mg + Diclofenac61.3
Tanezumab 10 mg + Diclofenac66.2
Week 16: >=40% reduction
GroupValue95% CI
Placebo + Diclofenac38.8
Tanezumab 2.5 mg + Diclofenac48.7
Tanezumab 5 mg + Diclofenac50.7
Tanezumab 10 mg + Diclofenac60.7
Week 16: >=50% reduction
GroupValue95% CI
Placebo + Diclofenac30.9
Tanezumab 2.5 mg + Diclofenac35.9
Tanezumab 5 mg + Diclofenac40.0
Tanezumab 10 mg + Diclofenac49.0
Week 16: >=60% reduction
GroupValue95% CI
Placebo + Diclofenac21.7
Tanezumab 2.5 mg + Diclofenac26.3
Tanezumab 5 mg + Diclofenac28.7
Tanezumab 10 mg + Diclofenac31.7
Week 16: >=70% reduction
GroupValue95% CI
Placebo + Diclofenac13.2
Tanezumab 2.5 mg + Diclofenac17.3
Tanezumab 5 mg + Diclofenac20.0
Tanezumab 10 mg + Diclofenac19.3
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF Secondary · Baseline, Weeks 2, 4, 8, 12, 16, and 24

WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale

Week 2: At least 30% reduction
GroupValue95% CI
Placebo + Diclofenac30.3
Tanezumab 2.5 mg + Diclofenac28.8
Tanezumab 5 mg + Diclofenac32.0
Tanezumab 10 mg + Diclofenac24.1
Week 2: At least 50% reduction
GroupValue95% CI
Placebo + Diclofenac13.8
Tanezumab 2.5 mg + Diclofenac16.0
Tanezumab 5 mg + Diclofenac16.7
Tanezumab 10 mg + Diclofenac9.0
Week 2: At least 70% reduction
GroupValue95% CI
Placebo + Diclofenac4.6
Tanezumab 2.5 mg + Diclofenac6.4
Tanezumab 5 mg + Diclofenac7.3
Tanezumab 10 mg + Diclofenac2.8
Week 2: At least 90% reduction
GroupValue95% CI
Placebo + Diclofenac2.0
Tanezumab 2.5 mg + Diclofenac1.3
Tanezumab 5 mg + Diclofenac1.3
Tanezumab 10 mg + Diclofenac0.7
Week 4: At least 30% reduction
GroupValue95% CI
Placebo + Diclofenac42.1
Tanezumab 2.5 mg + Diclofenac51.9
Tanezumab 5 mg + Diclofenac57.3
Tanezumab 10 mg + Diclofenac50.3
Week 4: At least 50% reduction
GroupValue95% CI
Placebo + Diclofenac17.1
Tanezumab 2.5 mg + Diclofenac26.9
Tanezumab 5 mg + Diclofenac34.0
Tanezumab 10 mg + Diclofenac30.3
Week 4: At least 70% reduction
GroupValue95% CI
Placebo + Diclofenac5.9
Tanezumab 2.5 mg + Diclofenac10.3
Tanezumab 5 mg + Diclofenac12.7
Tanezumab 10 mg + Diclofenac11.7
Week 4: At least 90% reduction
GroupValue95% CI
Placebo + Diclofenac2.0
Tanezumab 2.5 mg + Diclofenac1.9
Tanezumab 5 mg + Diclofenac6.0
Tanezumab 10 mg + Diclofenac2.1
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF Secondary · Weeks 2, 4, 8, 12, 16, and 24

Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Hig

Week 2
GroupValue95% CI
Placebo + Diclofenac5.9
Tanezumab 2.5 mg + Diclofenac5.8
Tanezumab 5 mg + Diclofenac4.7
Tanezumab 10 mg + Diclofenac5.5
Week 4
GroupValue95% CI
Placebo + Diclofenac6.6
Tanezumab 2.5 mg + Diclofenac3.2
Tanezumab 5 mg + Diclofenac14.7
Tanezumab 10 mg + Diclofenac12.4
Week 8
GroupValue95% CI
Placebo + Diclofenac5.3
Tanezumab 2.5 mg + Diclofenac6.4
Tanezumab 5 mg + Diclofenac18.0
Tanezumab 10 mg + Diclofenac14.5
Week 12
GroupValue95% CI
Placebo + Diclofenac6.6
Tanezumab 2.5 mg + Diclofenac6.4
Tanezumab 5 mg + Diclofenac14.0
Tanezumab 10 mg + Diclofenac12.4
Week 16
GroupValue95% CI
Placebo + Diclofenac4.6
Tanezumab 2.5 mg + Diclofenac5.8
Tanezumab 5 mg + Diclofenac14.7
Tanezumab 10 mg + Diclofenac16.6
Week 24
GroupValue95% CI
Placebo + Diclofenac5.9
Tanezumab 2.5 mg + Diclofenac5.8
Tanezumab 5 mg + Diclofenac12.7
Tanezumab 10 mg + Diclofenac12.4
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF) Secondary · Weeks 2, 4, 8, 12, 16, and 24

Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Hig

Week 2
GroupValue95% CI
Placebo + Diclofenac5.9
Tanezumab 2.5 mg + Diclofenac5.8
Tanezumab 5 mg + Diclofenac4.7
Tanezumab 10 mg + Diclofenac5.5
Week 4
GroupValue95% CI
Placebo + Diclofenac6.6
Tanezumab 2.5 mg + Diclofenac3.2
Tanezumab 5 mg + Diclofenac14.7
Tanezumab 10 mg + Diclofenac11.7
Week 8
GroupValue95% CI
Placebo + Diclofenac5.3
Tanezumab 2.5 mg + Diclofenac6.4
Tanezumab 5 mg + Diclofenac17.3
Tanezumab 10 mg + Diclofenac13.8
Week 12
GroupValue95% CI
Placebo + Diclofenac6.6
Tanezumab 2.5 mg + Diclofenac6.4
Tanezumab 5 mg + Diclofenac13.3
Tanezumab 10 mg + Diclofenac10.3
Week 16
GroupValue95% CI
Placebo + Diclofenac4.6
Tanezumab 2.5 mg + Diclofenac5.8
Tanezumab 5 mg + Diclofenac14.0
Tanezumab 10 mg + Diclofenac14.5
Week 24
GroupValue95% CI
Placebo + Diclofenac5.3
Tanezumab 2.5 mg + Diclofenac4.5
Tanezumab 5 mg + Diclofenac10.0
Tanezumab 10 mg + Diclofenac9.7
Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 Secondary · Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24

Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement.

Baseline
GroupValue95% CI
Placebo + Diclofenac6.31± 1.39
Tanezumab 2.5 mg + Diclofenac6.29± 1.30
Tanezumab 5 mg + Diclofenac6.38± 1.48
Tanezumab 10 mg + Diclofenac6.34± 1.31
Change at Week 1
GroupValue95% CI
Placebo + Diclofenac-0.55± 1.12
Tanezumab 2.5 mg + Diclofenac-0.74± 1.10
Tanezumab 5 mg + Diclofenac-1.22± 1.49
Tanezumab 10 mg + Diclofenac-0.96± 1.22
Change at Week 2
GroupValue95% CI
Placebo + Diclofenac-0.95± 1.43
Tanezumab 2.5 mg + Diclofenac-0.91± 1.40
Tanezumab 5 mg + Diclofenac-1.28± 1.76
Tanezumab 10 mg + Diclofenac-1.03± 1.46
Change at Week 3
GroupValue95% CI
Placebo + Diclofenac-1.19± 1.65
Tanezumab 2.5 mg + Diclofenac-1.19± 1.57
Tanezumab 5 mg + Diclofenac-1.40± 1.73
Tanezumab 10 mg + Diclofenac-1.08± 1.58
Change at Week 4
GroupValue95% CI
Placebo + Diclofenac-1.28± 1.65
Tanezumab 2.5 mg + Diclofenac-1.45± 1.70
Tanezumab 5 mg + Diclofenac-1.77± 1.74
Tanezumab 10 mg + Diclofenac-1.44± 1.73
Change at Week 6
GroupValue95% CI
Placebo + Diclofenac-1.38± 1.58
Tanezumab 2.5 mg + Diclofenac-1.57± 1.75
Tanezumab 5 mg + Diclofenac-1.88± 1.96
Tanezumab 10 mg + Diclofenac-1.69± 1.71
Change at Week 8
GroupValue95% CI
Placebo + Diclofenac-1.41± 1.64
Tanezumab 2.5 mg + Diclofenac-1.62± 1.75
Tanezumab 5 mg + Diclofenac-1.84± 2.00
Tanezumab 10 mg + Diclofenac-1.80± 1.83
Change at Week 10
GroupValue95% CI
Placebo + Diclofenac-1.41± 1.77
Tanezumab 2.5 mg + Diclofenac-1.79± 1.88
Tanezumab 5 mg + Diclofenac-2.09± 2.13
Tanezumab 10 mg + Diclofenac-2.06± 1.82

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo + Diclofenac
Serious: 8/152 (5%)
Deaths: —
Tanezumab 2.5 mg + Diclofenac
Serious: 12/157 (8%)
Deaths: —
Tanezumab 5 mg + Diclofenac
Serious: 8/150 (5%)
Deaths: —
Tanezumab 10 mg + Diclofenac
Serious: 10/145 (7%)
Deaths: —

Serious adverse events (32 terms)

ReactionSystemPlacebo + DiclofenacTanezumab 2.5 mg + Diclofe…Tanezumab 5 mg + DiclofenacTanezumab 10 mg + Diclofenac
OsteoarthritisMusculoskeletal and connective tissue disorders————
OsteonecrosisMusculoskeletal and connective tissue disorders————
Atrial fibrillationCardiac disorders————
Cardiac failureCardiac disorders————
Myocardial infarctionCardiac disorders————
Ventricular extrasystolesCardiac disorders————
Benign familial pemphigusCongenital, familial and genetic disorders————
Abdominal herniaGastrointestinal disorders————
Abdominal rigidityGastrointestinal disorders————
Gastrointestinal haemorrhageGastrointestinal disorders————
Large intestine perforationGastrointestinal disorders————
CholecystitisHepatobiliary disorders————
CholelithiasisHepatobiliary disorders————
BronchitisInfections and infestations————
OsteomyelitisInfections and infestations————
Ankle fractureInjury, poisoning and procedural complications————
FallInjury, poisoning and procedural complications————
Foot fractureInjury, poisoning and procedural complications————
Spinal column injuryInjury, poisoning and procedural complications————
Spinal fractureInjury, poisoning and procedural complications————
HyperkalaemiaMetabolism and nutrition disorders————
Pathological fractureMusculoskeletal and connective tissue disorders————
Synovial cystMusculoskeletal and connective tissue disorders————
Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
CholesteatomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Other adverse events (14 terms — click to expand)

ReactionSystemPlacebo + DiclofenacTanezumab 2.5 mg + Diclofe…Tanezumab 5 mg + DiclofenacTanezumab 10 mg + Diclofenac
NasopharyngitisInfections and infestations————
ArthralgiaMusculoskeletal and connective tissue disorders————
HeadacheNervous system disorders————
ToothacheGastrointestinal disorders————
HypertensionVascular disorders————
Oedema peripheralGeneral disorders————
InfluenzaInfections and infestations————
Back painMusculoskeletal and connective tissue disorders————
ParaesthesiaNervous system disorders————
DiarrhoeaGastrointestinal disorders————
BronchitisInfections and infestations————
Pain in extremityMusculoskeletal and connective tissue disorders————
DizzinessNervous system disorders————
SciaticaNervous system disorders————

Most-reported serious reactions: Osteoarthritis, Osteonecrosis, Atrial fibrillation, Cardiac failure, Myocardial infarction, Ventricular extrasystoles, Benign familial pemphigus, Abdominal hernia.

Data from ClinicalTrials.gov NCT00864097 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial.
    Balanescu AR, Feist E, Wolfram G, Davignon I, et al · · 2014 · cited 69× · PMID 23852695 · DOI 10.1136/annrheumdis-2012-203164
  2. Antibodies to watch in 2010.
    Reichert JM. · · 2010 · cited 68× · PMID 20065640 · DOI 10.4161/mabs.2.1.10677
  3. The potential role of synovial cells in the progression and treatment of osteoarthritis.
    Zou Z, Li H, Yu K, Ma K, et al · · 2023 · cited 57× · PMID 37933282 · DOI 10.1002/exp.20220132
  4. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip.
    Tive L, Bello AE, Radin D, Schnitzer TJ, et al · · 2019 · cited 37× · PMID 30936738 · DOI 10.2147/jpr.s191297
  5. Emerging pharmaceutical therapeutics and delivery technologies for osteoarthritis therapy.
    Shentu CY, Yan G, Xu DC, Chen Y, et al · · 2022 · cited 15× · PMID 36467045 · DOI 10.3389/fphar.2022.945876

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00864097.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing