NCT02215252 is a Phase 2 clinical trial of PF-05089771 150 mg in Diabetic Neuropathy, Painful, sponsored by Pfizer.

Who is sponsoring NCT02215252?

NCT02215252 is sponsored by Pfizer.

What drugs are being tested in NCT02215252?

Interventions in NCT02215252: PF-05089771 150 mg, Matched placebo for PF-05089771 150 mg and pregabalin 300 mg, Pregabalin 300 mg, PF-05089771 150 mg + Pregabalin 300 mg.

What condition does NCT02215252 study?

NCT02215252 studies Diabetic Neuropathy, Painful.

Is NCT02215252 still recruiting?

NCT02215252 is currently completed. Last updated 5 May 2017.

Are results published for NCT02215252?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-05-05 · How we verify

NCT02215252

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

Completed Phase 2 Results posted Last updated 5 May 2017

What this trial tests

Phase 2 trial testing PF-05089771 150 mg in Diabetic Neuropathy, Painful in 141 participants. Completed in 28 September 2015.

Timeline

10 November 2014

Primary endpoint
15 July 2015

28 September 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	141
Start date	10 November 2014
Primary completion	15 July 2015
Estimated completion	28 September 2015
Sites	32 locations across United States

Drugs / interventions tested

PF-05089771 150 mg — full drug profile →
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg — full drug profile →
Pregabalin 300 mg — full drug profile →
PF-05089771 150 mg + Pregabalin 300 mg — full drug profile →

Conditions studied

Diabetic Neuropathy, Painful — all drugs for Diabetic Neuropathy, Painful →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 80, any sex, with Diabetic Neuropathy, Painful. 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.

Daily Pain Numeric Rating Scale (NRS) Primary · Baseline, Week 1, Week 2, Week 3 and Week 4

The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	6.17	± 1.164
Pregabalin	6.62	± 1.420
Placebo	6.35	± 1.170

Week 1 (n = 44, 46, 44)

Group	Value	95% CI
PF-05089771 150 mg BID	5.45	± 1.372
Pregabalin	5.87	± 1.872
Placebo	6.07	± 1.454

Week 2 (n = 43, 44, 40)

Group	Value	95% CI
PF-05089771 150 mg BID	5.14	± 1.762
Pregabalin	5.26	± 2.302
Placebo	6.10	± 1.504

Week 3 (n = 38, 40, 41)

Group	Value	95% CI
PF-05089771 150 mg BID	5.01	± 1.820
Pregabalin	5.36	± 2.386
Placebo	5.76	± 1.540

Week 4 (n = 41, 38, 39)

Group	Value	95% CI
PF-05089771 150 mg BID	4.83	± 1.595
Pregabalin	5.14	± 2.508
Placebo	5.61	± 1.820

Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score Secondary · Baseline, Week 1, Week 2, Week 3 and Week 4

Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).

Week 1 (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	9.09
Pregabalin	15.22
Placebo	4.44

Week 2 (n = 44, 45, 44)

Group	Value	95% CI
PF-05089771 150 mg BID	22.73
Pregabalin	31.11
Placebo	9.09

Week 3 (n = 42, 42, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	23.81
Pregabalin	26.19
Placebo	11.63

Week 4 (n = 42, 38, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	28.57
Pregabalin	31.58
Placebo	16.28

Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score Secondary · Baseline, Week 1, Week 2, Week 3, and Week 4

Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).

Week 1 (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	0
Pregabalin	4.35
Placebo	4.44

Week 2 (n = 44, 45, 44)

Group	Value	95% CI
PF-05089771 150 mg BID	11.36
Pregabalin	15.56
Placebo	2.27

Week 3 (n = 42, 42, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	7.14
Pregabalin	19.05
Placebo	2.33

Week 4 (n = 42, 38, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	9.52
Pregabalin	23.68
Placebo	6.98

Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain Secondary · Baseline, Week 2, and Week 4

Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	4.6	± 2.71
Pregabalin	5.3	± 2.49
Placebo	4.8	± 2.35

Week 2 (n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	3.7	± 2.94
Pregabalin	4.3	± 3.06
Placebo	4.2	± 2.35

Week 4 (n = 42, 38, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	3.4	± 3.04
Pregabalin	4.3	± 2.80
Placebo	4.5	± 2.55

Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain Secondary · Baseline, Week 2 and Week 4

Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	3.8	± 2.48
Pregabalin	4.9	± 2.21
Placebo	4.5	± 2.40

Week 2 (n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	3.3	± 2.51
Pregabalin	4.4	± 2.83
Placebo	4.2	± 2.33

Week 4 (n = 42, 38, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	3.4	± 2.67
Pregabalin	3.9	± 3.08
Placebo	4.0	± 2.48

Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain Secondary · Baseline, Week 2, and Week 4

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	4.5	± 2.36
Pregabalin	5.8	± 2.18
Placebo	5.6	± 2.23

Week 2 (n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	4.1	± 2.61
Pregabalin	4.7	± 2.98
Placebo	4.9	± 2.11

Week 4 (n = 42, 38, 42）

Group	Value	95% CI
PF-05089771 150 mg BID	3.9	± 2.87
Pregabalin	4.6	± 2.83
Placebo	4.8	± 2.55

Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain Secondary · Baseline, Week 2 and Week 4

Baseline (n = 44, 45, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	2.7	± 2.38
Pregabalin	5.0	± 2.51
Placebo	4.2	± 2.42

Week 2 (n = 42, 40, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	2.0	± 1.92
Pregabalin	4.0	± 2.67
Placebo	3.5	± 2.47

Week 4 (n = 42, 37, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	2.3	± 2.24
Pregabalin	3.8	± 3.07
Placebo	3.6	± 2.53

Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia Secondary · Baseline, Week 2 and Week 4

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	5.7	± 2.02
Pregabalin	6.1	± 2.35
Placebo	6.6	± 1.96

Week 2 (n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	4.8	± 2.45
Pregabalin	5.3	± 2.83
Placebo	5.9	± 2.40

Week 4 (n = 42, 38, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	4.9	± 2.34
Pregabalin	5.4	± 2.84
Placebo	5.9	± 2.63

Neuropathic Pain Symptom Inventory (NPSI) - Total Score Secondary · Baseline, Week 2 and Week 4

Baseline (n = 44, 45, 45）

Group	Value	95% CI
PF-05089771 150 mg BID	40.6	± 17.33
Pregabalin	53.4	± 19.35
Placebo	50.7	± 16.87

Week 2 (n = 42, 40, 34)

Group	Value	95% CI
PF-05089771 150 mg BID	34.2	± 17.39
Pregabalin	44.6	± 24.64
Placebo	44.7	± 18.11

Week 4 (n = 42, 37, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	34.7	± 19.40
Pregabalin	42.7	± 27.23
Placebo	44.5	± 20.18

Patient's Global Impression of Change Score (PGIC). Secondary · Baseline, Week 2, and Week 4

Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".

Improved (Baseline, n = 43, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	20
Pregabalin	11
Placebo	16

Improved (Week 2, n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	27
Pregabalin	30
Placebo	26

Improved (Week 4, n = 42, 38, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	28
Pregabalin	27
Placebo	24

No change (Baseline, n = 43, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	19
Pregabalin	30
Placebo	25

No change (Week 2, n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	10
Pregabalin	7
Placebo	13

No change (Week 4, n = 42, 38, 42)

Group	Value	95% CI
PF-05089771 150 mg BID	12
Pregabalin	9
Placebo	14

Worse (Baseline, n = 43, 46, 35)

Group	Value	95% CI
PF-05089771 150 mg BID	4
Pregabalin	5
Placebo	4

Worse (Week 2, n = 42, 41, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	5
Pregabalin	4
Placebo	4

Daily Sleep Interference Scale Score (DSIS). Secondary · Baseline, Week 1, Week 2, Week 3 and Week 4

Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	4.7	± 2.42
Pregabalin	5.6	± 2.38
Placebo	4.9	± 2.29

Week 1 (n= 44, 46, 44)

Group	Value	95% CI
PF-05089771 150 mg BID	4.1	± 2.29
Pregabalin	4.7	± 2.55
Placebo	4.7	± 2.46

Week 2 (n = 43, 44, 40)

Group	Value	95% CI
PF-05089771 150 mg BID	4.0	± 2.33
Pregabalin	4.1	± 2.74
Placebo	4.7	± 2.41

Week 3 (n = 38, 40, 41)

Group	Value	95% CI
PF-05089771 150 mg BID	3.6	± 2.28
Pregabalin	4.4	± 2.71
Placebo	4.3	± 2.49

Week 4 (n = 41, 38, 39)

Group	Value	95% CI
PF-05089771 150 mg BID	3.4	± 2.13
Pregabalin	4.2	± 2.82
Placebo	4.3	± 2.51

Total Amount of Rescue Medication Per Week Secondary · Baseline, Week 1, Week 2, Week 3, and Week 4

Total amount of rescue medication participants take per week

Baseline (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	2726	± 4310
Pregabalin	3398	± 5723
Placebo	1863	± 3684

Week 1 (n = 44, 46, 45)

Group	Value	95% CI
PF-05089771 150 mg BID	2272	± 4043
Pregabalin	2897	± 5605
Placebo	1694	± 3425

Week 2 (n = 44, 45, 44)

Group	Value	95% CI
PF-05089771 150 mg BID	1669	± 3248
Pregabalin	2952	± 5488
Placebo	1391	± 3238

Week 3 (n = 42, 42, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	1851	± 3228
Pregabalin	1885	± 4918
Placebo	1306	± 3308

Week 4 (n = 42, 38, 43)

Group	Value	95% CI
PF-05089771 150 mg BID	1617	± 2945
Pregabalin	2328	± 5256
Placebo	1372	± 3307

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of placebo run-in until 28 days after last dose of placebo run-out, an average of 3 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PF-05089771 150 mg BID

Serious: 1/44 (2%)

Deaths: —

Pregabalin

Serious: 1/46 (2%)

Deaths: —

Placebo

Serious: 0/45 (0%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	PF-05089771 150 mg BID	Pregabalin	Placebo
Cardiac failure congestive	Cardiac disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	PF-05089771 150 mg BID	Pregabalin	Placebo
Dizziness	Nervous system disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Vulvovaginal pruritus	Reproductive system and breast disorders	—	—	—

Most-reported serious reactions: Cardiac failure congestive, Pneumonia, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT02215252 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

Publications & conference data

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

Pregabalin for neuropathic pain in adults.
Derry S, Bell RF, Straube S, Wiffen PJ, et al · · 2019 · cited 194× · PMID 30673120 · DOI 10.1002/14651858.cd007076.pub3
Nav1.7 and other voltage-gated sodium channels as drug targets for pain relief.
Emery EC, Luiz AP, Wood JN. · · 2016 · cited 152× · PMID 26941184 · DOI 10.1517/14728222.2016.1162295
Efficacy of the Nav1.7 blocker PF-05089771 in a randomised, placebo-controlled, double-blind clinical study in subjects with painful diabetic peripheral neuropathy.
McDonnell A, Collins S, Ali Z, Iavarone L, et al · · 2018 · cited 134× · PMID 29578944 · DOI 10.1097/j.pain.0000000000001227
Voltage gated sodium channels as therapeutic targets for chronic pain.
Ma RSY, Kayani K, Whyte-Oshodi D, Whyte-Oshodi A, et al · · 2019 · cited 49× · PMID 31564962 · DOI 10.2147/jpr.s207610
Lack of Detection of the Analgesic Properties of PF-05089771, a Selective Na<sub>v</sub> 1.7 Inhibitor, Using a Battery of Pain Models in Healthy Subjects.
Siebenga P, van Amerongen G, Hay JL, McDonnell A, et al · · 2020 · cited 44× · PMID 31642607 · DOI 10.1111/cts.12712
Inhibition of Na<sub>V</sub>1.7: the possibility of ideal analgesics.
Kitano Y, Shinozuka T. · · 2022 · cited 13× · PMID 36092147 · DOI 10.1039/d2md00081d

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02215252 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 5 May 2017

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/NCT02215252.

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

NCT02215252

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetic Neuropathy, Painful

Other Pfizer trials

Verify against primary sources