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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: FDC IBU/APAP 250 mg/500 mg

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Pharmaceutical Research Associates, Inc.

Participation Criteria

Eligibility Criteria

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

Description

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.

   .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose
Duration of Relief 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.	Up to 8 hours after first dose
Time to Onset of "Meaningful" Pain Relief 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.	Up to 8 hours after first dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Ibuprofen, acetaminophen, pain, molar extraction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache
• Other Study ID Numbers: B5061004; GEMINI MDDP (Other Identifier: Alias Study Number); MDDP (Other Identifier: Alias Study Number)