EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN
Overview
- Phase
- Phase 2
- Intervention
- Ibuprofen/acetaminophen
- Conditions
- Pain
- Sponsor
- Pfizer
- Enrollment
- 394
- Locations
- 1
- Primary Endpoint
- Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females 16 to 40 years of age
- •Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth
Exclusion Criteria
- •Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
- •Pregnant or breastfeeding females
Arms & Interventions
Ibuprofen/acetaminophen (lower dose)
Intervention: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (middle dose)
Intervention: Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (high dose)
Intervention: Ibuprofen/acetaminophen
Ibuprofen
Intervention: Ibuprofen
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
Time Frame: From 0 hour up to 8 hours post-dose
SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 \[none\] to 3 \[severe\]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief.
Secondary Outcomes
- Pain Intensity Difference on 4-Point Categorical Scale (PID4)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Pain Intensity Difference on 11-Point Numerical Scale (PID11)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Cumulative Percentage of Participants With Treatment Failure(1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time to Confirmed First Perceptible Relief(From 0 hour up to 12 hours post-dose)
- Pain Relief Rating Score (PRR)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose(0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose)
- Cumulative Percentage of Participants With Meaningful Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Time to Onset of Meaningful Pain Relief(From 0 hour up to 12 hours post-dose)
- Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose(0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose)
- Cumulative Percentage of Participants With Confirmed First Perceptible Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose)
- Time to Treatment Failure(From 0 hour up to 12 hours post-dose)
- Participant Global Evaluation of Study Medication(12 hour)