Civamide in OA of the Knee(s)
The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects With Osteoarthritis of the Knee(s)|
|Study Start Date:||November 2003|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
This is a 52-week open label study wherein subjects are required to apply the study drug on the knee(s) three times a day. Subjects are required to return to the clinic every 13 weeks.
Enrollment Visit (Day 1) At the End-of-Study/Final Visit, Day 84 of Study No. WL-1001-05-01 (or preferably < 30 days following this visit) subjects will be invited to enroll in this long-term open label Study WL-1001-05-04. Subjects will sign a written informed consent prior to being enrolled into the long-term open label study. If enrolled at the final visit or < 30 days after the final visit of Study No. WL-1001-05-01, the final visit physical examination and laboratory examination will serve as baseline for this study. If enrolled > 30 days after the final visit, a new physical examination and laboratory examination will be completed upon enrollment into this study. The subjects will complete an OA Pain Score and Subject Global Evaluation (SGE) for their Target Knee, the same knee designated as the Target Knee in Study No. WL-1001-05-01. A 13-week supply of study drug and subject diaries for the next 13 weeks will be dispensed to each subject. Instructions on how to apply the study drug will be reviewed with the subjects. Subjects will also be instructed to complete their diaries daily (Adverse Events Log and Other Medications Log) and to return their completed diaries and study drug tubes at each clinic visit.
Treatment Period (Days 1- 365) Subjects will apply study drug to their Target Knee three times a day for 52 weeks. If the subject's other knee is affected by osteoarthritis pain, it may be treated with the study drug as well. The study drug tubes will be weighed prior to being dispensed to the subject. Each tube will also be weighed when the subject returns them.
At each clinic visit, the study staff will review the diaries with each subject for completeness and legibility.
Subjects will complete the OA Pain Score and Subject Global Evaluation at clinic visits on Day 1 and Weeks 13, 26, 39, and 52. Concurrent medications, adverse events, and study drug compliance will be reviewed and recorded by the study staff throughout the Treatment Period at clinic visits on Weeks 13, 26, 39, and 52 (End-of-Study/Final Visit). At the week 52 visit (End-of-Study/Final Visit), a physical examination and laboratory examination will be performed.
On Day 365 (End-of-Study/Final Visit) the subject will be discharged after all procedures have been completed.
Show 34 Study Locations
|Study Director:||Scott B. Phillips, M.D.||Winston Laboratories|