Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

Phase 3

Completed

Conditions: Pain

Interventions: Drug: Placebo
Drug: Novel Ibuprofen
Drug: Acetaminophen

Registration Number: NCT01216163

Lead Sponsor: Pfizer

Brief Summary: This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 218

Inclusion Criteria

Normal, healthy males and females 16 to 40 years of age
Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

Exclusion Criteria

Pregnancy or breast-feeding
Alcohol or substance abuse
Any serious medical or psychiatric disorder
History of stomach ulcers, stomach bleed, or other bleeding disorders
Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants [including alcohol])

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment C	Placebo	-
Treatment A	Novel Ibuprofen	-
Treatment B	Acetaminophen	-

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)	0 to 6 hours	SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time to Onset of Meaningful Relief	0 to 6 hours	Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.

Secondary Outcome Measures

Name	Time	Method
Time to Confirmed First Perceptible Relief	0 to 6 hours	Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Pain Relief Rating (PRR)	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Pain Intensity Difference (PID)	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best).
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 \[none\] to 3 \[severe\]) from the baseline score (Baseline pain severity score range 2 \[moderate\] to 3 \[severe\]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
Time-weighted Sum of Pain Intensity Difference (SPID)	0 to 2, 0 to 3, 0 to 6 hours	SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best).
Time-weighted Sum of Pain Relief Rating (TOTPAR)	0 to 2, 0 to 3, 0 to 6 hours	TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)	0 to 2, 0 to 3 hours	SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Cumulative Percentage of Participants With Meaningful Relief	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Cumulative Percentage of Participants With Confirmed First Perceptible Relief	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
Time to Treatment Failure	0 to 6 hours	Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.
Cumulative Percentage of Participants With Treatment Failure	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
Cumulative Percentage of Participants With Complete Relief	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
Participant Global Evaluation of Study Medication	6 hours	Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.