Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee
A Phase III Study of the Efficacy, Tolerability and Safety of the Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee, Including a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase Followed by an Open-Label Treatment Phase
1 other identifier
interventional
300
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 19, 2020
February 1, 2020
8 months
August 16, 2006
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain as measured by the pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at Week 2
Secondary Outcomes (6)
Pain intensity, pain relief (diary)
Functional disability
Use of prn rescue medication
Quality of sleep
Lost days of work
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Males or females 18 years of age or older
- Diagnosis of osteoarthritis of the knee (unilateral or bilateral)
- Meet pain entry criteria
- Willing to discontinue use of all analgesic medications (including over-the-counter \[OTC\] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.
You may not qualify if:
- Positive urine pregnancy test, pregnant or lactating.
- Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease
- Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
- Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
- Have a history or physical examination finding that is incompatible with safe participation in the study or study product use
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
- Have significant renal or hepatic impairment
- Are taking a sleep medication at a dose that has not been stable for at least 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD
Austin, Texas, 78704, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PPD
PPD Development, LP
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 17, 2006
Study Start
August 1, 2006
Primary Completion
April 1, 2007
Study Completion
May 1, 2007
Last Updated
February 19, 2020
Record last verified: 2020-02