Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211549
Status:
COMPLETED
Last Update Posted:
2009-03-20
First Post:
2005-09-13
Brief Title:
An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
Sponsor:
IDEA AG
Organization:
IDEA AG
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify the doses of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee
Detailed Description:
The objective of this double-blind placebo-controlled randomized study is to evaluate the safety of and to identify the doses of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain WOMAC Physical Function and Subject Global Assessment of Response to Therapy A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033
Patients will receive one of five treatments for 12 weeksThree doses of IDEA-033 or naproxen 1 g over-encapsulated tablet placebo or placebo
Patients will receive one of five treatments for 12 weeksThree doses of IDEA-033 or naproxen 1 g over-encapsulated tablet placebo or placebo
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