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Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

NCT01559259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2020-05-19

Study results available
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Summary

This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.

Conditions

Interventions

DRUG

Ibuprofen/acetaminophen

Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg

DRUG

Ibuprofen/acetaminophen

Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg

DRUG

Ibuprofen/acetaminophen

Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg

DRUG

Ibuprofen

Two caplets of ibuprofen 200 mg

DRUG

Placebo

Two caplets of placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-10
Primary Completion
2012-09-13
Completion
2012-09-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01559259 on ClinicalTrials.gov