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

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426985

Enrollment

381

Registered

2007-01-26

Start date

2007-02-07

Completion date

2008-03-10

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bursitis, Tendonitis

Keywords

Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders

Brief summary

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

Detailed 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.

Interventions

DRUGKetoprofen Topical Patch 20%

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Average pain intensity during daily activities	—

Secondary

Measure	Time frame
Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep	—

Countries

United States

Contacts

STUDY_DIRECTORPPD

PPD Development, LP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026