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Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

NCT01266161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2018-08-15

Study results available
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Summary

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Conditions

Interventions

DRUG

Ibuprofen 600 mg ER

One 600 mg caplet dosed at 0, 12, 24 and 36 hours

DRUG

Placebo

One placebo caplet dosed at times 0, 12, 24 and 36 hours

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-11-22
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

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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 NCT01266161 on ClinicalTrials.gov