Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diclofenac Test (lower dose)

Group Type EXPERIMENTAL

Diclofenac Test (lower dose)

Intervention Type DRUG

Capsules

Diclofenac Test (upper dose)

Group Type EXPERIMENTAL

Diclofenac Test (upper dose)

Intervention Type DRUG

Capsules

Celecoxib

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

200 mg Capsules

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules

Interventions

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Diclofenac Test (lower dose)

Capsules

Intervention Type DRUG

Diclofenac Test (upper dose)

Capsules

Intervention Type DRUG

Celecoxib

200 mg Capsules

Intervention Type DRUG

Placebo

Capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No