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

• ClinicalTrials.gov Identifier: NCT02837952
• Recruitment Status: Completed
• First Posted: July 20, 2016
• Results First Posted: March 5, 2018
• Last Update Posted: March 5, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: FDC IBU/APAP 250 mg/500 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Double-blind, Randomized Safety And Efficacy Study Comparing Multiple Administrations Of Ibu 250 Mg/Apap 500 Mg (Administered As Two Tablets Of Ibu/Apap 125 Mg/250 Mg) To Placebo In The Treatment Of Post Surgical Dental Pain In Adult Subjects
• Actual Study Start Date: August 31, 2016
• Actual Primary Completion Date: February 1, 2017
• Actual Study Completion Date: February 1, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg; FDC IBU/APAP 250 mg/500 mg	Drug: FDC IBU/APAP 250 mg/500 mg; FDC IBU/APAP 250 mg/500 mg
Placebo Comparator: Placebo; Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24]) [ Time Frame: 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 :

1. 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 [ Time Frame: 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).
2. Duration of Relief After First Dose [ Time Frame: 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.
3. Time to Onset of "Meaningful" Pain Relief After First Dose [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria

1. Males and females 18 years to 40 years of age (inclusive).
2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
3. Subject must have at least moderate pain on the 4 point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (ie, less than or equal to 5 hours, 15 minutes) after surgery is completed.
4. In general good health and have no contraindications to the study or rescue medication.

Exclusion Criteria

1. Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening of the following medical conditions/disorders:

   • Gastrointestinal ulcer or gastrointestinal bleeding;
   • Paralytic ileus or other gastrointestinal obstructive disorders;
   • Bleeding disorder.
2. Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.

3. Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.

   .

Contacts and Locations

Locations

United States, Utah

Pharmaceutical Research Associates, Inc.

Salt Lake City, Utah, United States, 84106

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] February 9, 2017

Statistical Analysis Plan  [PDF] March 3, 2017

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02837952
• Other Study ID Numbers: B5061004; GEMINI MDDP ( Other Identifier: Alias Study Number ); MDDP ( Other Identifier: Alias Study Number )
• First Posted: July 20, 2016
• Results First Posted: March 5, 2018
• Last Update Posted: March 5, 2018
• Last Verified: January 2018

Keywords provided by Pfizer:

Ibuprofen, acetaminophen, pain, molar extraction

Additional relevant MeSH terms:

Toothache; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations