Adults 18 to 50, any sex, with Pain. 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.
Summed Pain Intensity Difference Over 0 to 12 Hours (SPID12) After Time 0Primary· 0-12 hours
SPID12 was used to compare the test product (2 × 300 mg ibuprofen PR tablets) and comparator product (2 × 200 mg ibuprofen IR tablets three times a day \[TID\]) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID12 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 12 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of
Group
Value
95% CI
Prolonged Release Group
51.84
± 21.457
Immediate Release Group
56.33
± 18.769
Placebo Group
19.11
± 24.630
Summed Pain Intensity Difference Over 0 to 24 Hours (SPID24) After Time 0Secondary· 0-24 hours
SPID24 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID24 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 24 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The mi
Group
Value
95% CI
Prolonged Release Group
115.75
± 46.146
Immediate Release Group
121.90
± 37.263
Placebo Group
64.32
± 55.070
Summed Pain Intensity Difference Over 0 to 4 Hours (SPID4) After Time 0Secondary· 0-4 hours
SPID4 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID4 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 4 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minim
Group
Value
95% CI
Prolonged Release Group
14.68
± 9.752
Immediate Release Group
16.99
± 7.884
Placebo Group
1.24
± 8.346
Summed Pain Intensity Difference Over 0 to 8 Hours (SPID8) After Time 0Secondary· 0-8 hours
SPID8 was used to compare the test product (2 × 300 mg ibuprofen PR tablets BID) and comparator product (2 × 200 mg ibuprofen IR tablets TID) against the placebo product. An 11-point (0-10) numeric rating scale (NRS) for pain was used to assess pain intensity, where a higher score indicates a greater amount of pain. SPID8 was calculated using the summed pain intensity difference (change from Time 0) under the NRS-time curve from 15 minutes through 8 hours calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minim
Group
Value
95% CI
Prolonged Release Group
33.13
± 16.195
Immediate Release Group
34.48
± 13.001
Placebo Group
11.00
± 14.571
Sum of Total Pain Relief Over 0 to 4 Hours (TOTPAR4) After Time 0Secondary· 0-4 hours
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR4 is the total pain relief measured by the PRS from 15 minutes through 4 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR4 is 0 (no pain relief from Time 0 to 4 hours); the theoretical maximum is 16 (if a patient
Group
Value
95% CI
Prolonged Release Group
8.08
± 4.337
Immediate Release Group
8.98
± 3.365
Placebo Group
1.98
± 3.285
Sum of Total Pain Relief Over 0 to 8 Hours (TOTPAR8) After Time 0Secondary· 0-8 hours
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR8 is the total pain relief measured by the PRS from 15 minutes through 8 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR8 is 0 (no pain relief from Time 0 to 8 hours); the theoretical maximum is 32 (if a patient
Group
Value
95% CI
Prolonged Release Group
18.08
± 7.314
Immediate Release Group
18.41
± 5.764
Placebo Group
7.89
± 5.642
Sum of Total Pain Relief Over 0 to 12 Hours (TOTPAR12) After Time 0Secondary· 0-12 hours
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR12 is the total pain relief measured by the PRS from 15 minutes through 12 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR12 is 0 (no pain relief from Time 0 to 12 hours); the theoretical maximum is 48 (if a pat
Group
Value
95% CI
Prolonged Release Group
28.13
± 9.981
Immediate Release Group
29.981
± 8.538
Placebo Group
12.76
± 9.270
Sum of Total Pain Relief Over 0 to 24 Hours (TOTPAR24) After Time 0Secondary· 0-24 hours
A 5-point categorical Pain Relief Scale (PRS) with choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4 was completed in response to the question "How much relief have you had since your starting pain?". Higher scores indicate a better outcome. TOTPAR24 is the total pain relief measured by the PRS from 15 minutes through 24 hours, calculated using the linear trapezoidal rule and the actual time points, where Time 0 is the time of the first dose of study drug. The minimum value of TOTPAR24 is 0 (no pain relief from Time 0 to 24 hours); the theoretical maximum is 96 (if a pat
Group
Value
95% CI
Prolonged Release Group
62.32
± 20.504
Immediate Release Group
64.63
± 16.774
Placebo Group
36.96
± 22.153
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 4 Hours (SPRID4) After Time 0Secondary· 0-4 hours
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 4 hours (SPRID4) was determined by calculating the difference in the PRS at the 4-hour time point and the 0-hour time point (TOTPAR4) and adding this value to the difference in the NRS for pain at the 4-hour time point and the 0-hour time point (SPID4). The minimum value of SPRID4 is 0; the theoretical maximum is 56; a higher SPRID4 score indicates a better outcome.
Group
Value
95% CI
Prolonged Release Group
22.76
± 13.870
Immediate Release Group
25.97
± 11.011
Placebo Group
3.22
± 11.464
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 8 Hours (SPRID8) After Time 0Secondary· 0-8 hours
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 8 hours (SPRID8) was determined by calculating the difference in the PRS at the 8-hour time point and the 0-hour time point (TOTPAR8) and adding this value to the difference in the NRS for pain at the 8-hour time point and the 0-hour time point (SPID8). The minimum value of SPRID8 is 0; the theoretical maximum is 112; a higher SPRID8 score indicates a better outcome.
Group
Value
95% CI
Prolonged Release Group
51.21
± 22.985
Immediate Release Group
52.88
± 18.156
Placebo Group
18.89
± 19.916
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 12 Hours (SPRID12) After Time 0Secondary· 0-12 hours
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 12 hours (SPRID12) was determined by calculating the difference in the PRS at the 12-hour time point and the 0-hour time point (TOTPAR12) and adding this value to the difference in the NRS for pain at the 12-hour time point and the 0-hour time point (SPID12). The minimum value of SPRID12 is 0; the theoretical maximum 168; a higher SPRID12 score indicates a better outcome.
Group
Value
95% CI
Prolonged Release Group
79.97
± 30.643
Immediate Release Group
86.24
± 26.260
Placebo Group
31.87
± 33.539
Summed Pain Relief and Intensity Difference (Sum of TOTPAR and SPID [SPRID]) Over 0 to 24 Hours (SPRID24) After Time 0Secondary· 0-24 hours
The summed pain relief and intensity difference (sum of TOTPAR and SPID \[SPRID\]) over 0 to 24 hours (SPRID24) was determined by calculating the difference in the PRS at the 24-hour time point and the 0-hour time point (TOTPAR24) and adding this value to the difference in the NRS for pain at the 24-hour time point and the 0-hour time point (SPID24). The minimum value of SPRID24 is 0; the theoretical maximum is 336; a higher SPRID24 score indicates a better outcome.
Group
Value
95% CI
Prolonged Release Group
178.07
± 64.783
Immediate Release Group
186.53
± 51.842
Placebo Group
101.28
± 76.562
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were monitored and recorded from the time of signing of the informed consent form until the Follow-up Visit (or Early Termination Visit); a period of up to 30 days. Only treatment-emergent adverse events (those that started or worsened in intensity or relationship to treatment on or after the first dose of study drug) are reported here..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Reckitt Benckiser Healthcare (UK) Limited
Last refreshed: 3 June 2024
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/NCT03785756.