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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Placebo; Drug: FDC IBU/APAP 250 mg/500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02837952

MDDP (Other Identifier)

GEMINI MDDP (Other Identifier)

B5061004

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

   .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups, including a placebo group

Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg

Active Comparator group

Description:

FDC IBU/APAP 250 mg/500 mg

Treatment:

Drug: FDC IBU/APAP 250 mg/500 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo