A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: FDC IBU/APAP 250 mg/500 mg; Drug: Placebo

• Registration Number: NCT02837952
• Lead Sponsor: Pfizer

Brief Summary

This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2016-08-31
• Primary Completion: 2017-02-01
• Study Completion: 2017-02-01
• Status Verified: 2018-01
• Results First Submitted: 2018-01-31
• Results First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Results First Posted: 2018-03-05
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg	FDC IBU/APAP 250 mg/500 mg	FDC IBU/APAP 250 mg/500 mg
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24])	0 to 24 hours post dose	Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).

Secondary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose	0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose	Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 \[0-8\]), -15 (worst score) to 30 (best score) for (SPID11 \[6-8\]), -80 (worst score) to 160 (best score) for (SPID11 \[0-16\]), -45 (worst score) to 90 (best score) for (SPID11 \[8-16\]), -240 (worst score) to 480 (best score) for (SPID11 \[0-48\]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time to Onset of "Meaningful" Pain Relief After First Dose	Up to 8 hours after first dose	Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first.
Duration of Relief After First Dose	Up to 8 hours after first dose	Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.; 🇺🇸 Salt Lake City, Utah, United States