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Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

NCT00964431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2012-05-22

Study results available
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Summary

The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.

Conditions

  • Dental Pain

Interventions

DRUG

Celecoxib 400 mg

Capsules 2 x 200 mg Single-Dose

DRUG

Placebo

Capsules 2 Single-Dose

DRUG

Indomethacin Test (lower dose)

20-mg single dose

DRUG

Indomethacin Test (upper dose)

40-mg single dose

Sponsors & Collaborators

  • Iroko Pharmaceuticals, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00964431 on ClinicalTrials.gov