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Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

NCT01462435 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2014-02-04

Study results available
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Summary

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.

Conditions

  • Other Acute Postoperative Pain

Interventions

DRUG

Diclofenac Test (lower dose)

Capsules

DRUG

Diclofenac Test (upper dose)

Capsules

DRUG

Celecoxib

200 mg Capsules

DRUG

Placebo

Capsules

Sponsors & Collaborators

  • Iroko Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Michael Golf, DPM · Premier Research Group Limited

  • Ira Gottlieb, DPM · Chesapeake Research Group, LLC

  • Kyle Patrick, DO · Premier Research Group Limited

  • S. Thomas Schiffgen, DPM · Premier Research Group Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-02-29
Completion
2012-08-31

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 NCT01462435 on ClinicalTrials.gov