Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Xanodyne Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: diclofenac potassium (XP21L)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366444

XP21L-301

Details and patient eligibility

About

A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

Enrollment: 201 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-65 years of age
• Have undergone bunionectomy surgery
• Have achieved adequate post-surgical pain

Exclusion criteria

• Confounding medical conditions which preclude study participation
• Participated in a study of another investigational drug or device within 30 days prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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201 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: diclofenac potassium (XP21L)

2

Placebo Comparator group

Treatment:

Drug: Placebo