Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Completed · Phase 3 · Has a placebo group

Conditions studied: Other Acute Postoperative Pain

In brief

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

Key facts

Study ID: NCT01462435
Run by: Iroko Pharmaceuticals, LLC
People needed: 428
Starts: 2011-10-01
Expected to finish: 2012-08-01
Last updated by the study team: 2014-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

You may not qualify if…

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening

Where it is running

Premier Research Group Limited — Phoenix, Arizona, United States
Chesapeake Research Group, LLC — Pasadena, Maryland, United States
Premier Research Group Limited — Austin, Texas, United States
Premier Research Group Limited — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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