Overview

Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Imprimis Pharmaceuticals, Inc.
Treatments:
Ketoprofen
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.