Status:
WITHDRAWN
Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
Lead Sponsor:
Imprimis Pharmaceuticals, Inc.
Conditions:
Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.
Eligibility Criteria
Inclusion
- Clinical diagnosis of OA of the knee according to the ACR criteria.
- Kellgren-Lawrence grade 2-3 disease
- Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.
Exclusion
- Total knee replacement surgery tentatively scheduled within next 6 months.
- Palpable knee effusion.
- Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.
- Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.
- History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.
- History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.
- Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.
- Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01890902
Start Date
August 1 2013
Last Update
November 13 2013
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