Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04683627
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-12-21
Brief Title:
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
Sponsor:
Noven Pharmaceuticals Inc
Organization:
Noven Therapeutics
Study Overview
Official Title:
A 12-Week Randomized Double-blind Placebo-controlled Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System Patch in Subjects With Osteoarthritis Pain of the Knee
Status:
COMPLETED
Status Verified Date:
2023-07
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:
A 12-week Randomized Double-blind Placebo-controlled Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis OA Pain of the Knee
Detailed Description:
This is a multi-center randomized double-blind and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter OTC analgesics a 12-week Double-blind Treatment Phase and a 1-week safety Follow-up Phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None