Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis

Endo Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Tendonitis

Bursitis

Treatments

Drug: Ketoprofen Topical Patch 20%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00426985

EN3269-304

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

Full description

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.

Enrollment

330 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females 18 years of age or older
Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
Meet pain entry criteria
Willing to discontinue use of any pain medication not provided by study

Exclusion criteria

Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
Have received corticosteroids in the 30 days preceding screening
Have a history or physical examination finding that is incompatible with safe participation in the study
Have a history or physical examination finding that is incompatible with study product use
Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
Are taking medications that may significantly affect renal function