Civamide Patch Safety, Tolerability and PK Study
To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers|
- Subject's Rating of Stinging and Burning Sensation [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Civamide patch 0.0075%
Civamide patch 0.0075% q.d. 24 hours for 7 days
Other Name: Civamide
Active Comparator: 2
Civamide patch 0.0150%
Civamide patch 0.0150% q.d. 24 hours for 7 days
Other Name: Civamide
Placebo Comparator: 3
Drug: Placebo patch
Placebo patch q.d. 24 hours for 7 days
Other Name: placebo
This is a double-blind, randomized study of the tolerability of two different strengths of a Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21 to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects on Day 10.
Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset of subjects. Subjects will also rate stinging and burning sensation at the application site during the Treatment Period.
Twenty-four (24) hours after the last patch application, subjects will return to the study site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global Rating of Tolerability.
|United States, New York|
|International Research Services, Inc.|
|Port Chester, New York, United States, 10573|
|Study Director:||Scott B Phillips, M.D.||Winston Laboratories|