Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Iroko Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Other Acute Postoperative Pain

Treatments: Drug: Celecoxib; Drug: Diclofenac Test (upper dose); Drug: Diclofenac Test (lower dose); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01462435

DIC3-08-04

Details and patient eligibility

About

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

Enrollment: 428 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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428 participants in 4 patient groups, including a placebo group

Diclofenac Test (lower dose)

Experimental group

Treatment:

Drug: Diclofenac Test (lower dose)

Diclofenac Test (upper dose)

Experimental group

Treatment:

Drug: Diclofenac Test (upper dose)

Celecoxib

Active Comparator group

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo