- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00352625
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
February 17, 2020 updated by: APR Applied Pharma Research s.a.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 (in a 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.
Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
Ibuprofen will be provided as prn rescue medication.
Study Type
Interventional
Enrollment
330
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78704
- PPD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion
- 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 the study
Exclusion:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Average pain intensity during daily activities
|
Secondary Outcome Measures
Outcome Measure |
---|
Average pain intensity while at rest
|
Functional disability
|
Use of prn rescue medication
|
Quality of sleep
|
Patient's and physician's global assessments of study medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: PPD, PPD Austin, TX
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
July 12, 2006
First Posted (Estimate)
July 14, 2006
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 17, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Tendinopathy
- Bursitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketoprofen
Other Study ID Numbers
- EN3269-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bursitis
-
University of AlexandriaCompleted
-
Mackay Memorial HospitalCompleted
-
Keesler Air Force Base Medical CenterCompleted
-
University Hospital, GenevaCompletedOlecranon Bursitis | Patellar BursitisSwitzerland
-
Taipei Medical University Shuang Ho HospitalRecruiting
-
Universidade Estadual de LondrinaRecruiting
-
Taipei Medical UniversityNot yet recruitingInjection | Effect of Drug | Subdeltoid BursitisTaiwan
-
Sultan Abdulhamid Han Training and Research Hospital...CompletedTrochanteric BursitisTurkey
-
Universidade Estadual de LondrinaRecruiting
-
The University of Texas Health Science Center,...Pacira PharmaceuticalsCompletedTrochanteric BursitisUnited States
Clinical Trials on Ketoprofen Topical Patch 20%
-
Hisamitsu Pharmaceutical Co., Inc.Completed
-
Hisamitsu Pharmaceutical Co., Inc.Completed
-
Hisamitsu Pharmaceutical Co., Inc.CompletedOsteoarthritis of the KneeUnited States
-
APR Applied Pharma Research s.a.CompletedTendonitis of the Shoulder, Elbow, or KneeUnited States
-
APR Applied Pharma Research s.a.CompletedSprain | StrainUnited States
-
APR Applied Pharma Research s.a.CompletedOsteoarthritisUnited States
-
Endo PharmaceuticalsTerminatedBursitis | TendonitisUnited States
-
Hisamitsu Pharmaceutical Co., Inc.Completed
-
ZARS Pharma Inc.CompletedOsteoarthritisUnited States
-
Northwell HealthSolace Brands, Inc.WithdrawnOsteoarthritis | Knee Osteoarthritis | CBDUnited States