Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee Clinical Trial
Official title:
A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
| NCT number | NCT01890902 |
| Other study ID # | IPI-110-002 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 3 |
| First received | June 27, 2013 |
| Last updated | November 8, 2013 |
| Start date | August 2013 |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Imprimis Pharmaceuticals, Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8. | Day 4, 6 and 8 | No | |
| Secondary | Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8. | Day 8 | No |