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

Pain Clinical Trial

Official title:

Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216163
• Other study ID #: AH-09-14
• Secondary ID: B3411002
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2010
• Last updated: July 13, 2012
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Novel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
• Acetaminophen
Single-dose of acetaminophen (1000mg)
• Placebo
Single-dose of placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)	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).	0 to 6 hours	No
Primary	Time to Onset of Meaningful Relief	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.	0 to 6 hours	No
Secondary	Time to Confirmed First Perceptible Relief	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.	0 to 6 hours	No
Secondary	Pain Relief Rating (PRR)	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.	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Pain Intensity Difference (PID)	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).	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Sum of Pain Relief Rating and Pain Intensity Difference (PRID)	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).	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Time-weighted Sum of Pain Intensity Difference (SPID)	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).	0 to 2, 0 to 3, 0 to 6 hours	No
Secondary	Time-weighted Sum of Pain Relief Rating (TOTPAR)	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.	0 to 2, 0 to 3, 0 to 6 hours	No
Secondary	Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)	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).	0 to 2, 0 to 3 hours	No
Secondary	Cumulative Percentage of Participants With Meaningful Relief	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.	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Cumulative Percentage of Participants With Confirmed First Perceptible Relief	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.	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Time to Treatment Failure	Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first.	0 to 6 hours	No
Secondary	Cumulative Percentage of Participants With Treatment Failure	Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Cumulative Percentage of Participants With Complete Relief	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.	0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours	No
Secondary	Participant Global Evaluation of Study Medication	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.	6 hours	No

External Links

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