Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077935
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2004-02-13
Brief Title:
Civamide in OA of the Knees
Sponsor:
Winston Laboratories
Organization:
Winston Laboratories
Study Overview
Official Title:
An Open-Label Multicenter Study Evaluating the Safety of Civamide Cream 0075 as a Treatment in Subjects With Osteoarthritis of the Knees
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of Civamide Cream 0075 as a Treatment in Subjects with Osteoarthritis OA of the Knees
Detailed Description:
This is a 52-week open label study wherein subjects are required to apply the study drug on the knees three times a day Subjects are required to return to the clinic every 13 weeks
Enrollment Visit Day 1 At the End-of-StudyFinal 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 subjects 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-StudyFinal Visit At the week 52 visit End-of-StudyFinal Visit a physical examination and laboratory examination will be performed
On Day 365 End-of-StudyFinal Visit the subject will be discharged after all procedures have been completed
Enrollment Visit Day 1 At the End-of-StudyFinal 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 subjects 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-StudyFinal Visit At the week 52 visit End-of-StudyFinal Visit a physical examination and laboratory examination will be performed
On Day 365 End-of-StudyFinal Visit the subject will be discharged after all procedures have been completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None