Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246168
Status:
COMPLETED
Last Update Posted:
2010-11-30
First Post:
2005-10-28
Brief Title:
ULTRACET Tramadol Hydrochloride and Acetaminophen for the Treatment of Rheumatoid Arthritis Pain
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
Official Title:
ULTRACET Tramadol Hydrochloride and Acetaminophen add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis A Randomized Double-blind Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2010-11
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 assess the effectiveness of ULTRACET a combination analgesic as add-on therapy in rheumatoid arthritis patients taking an NSAID eg Advil Motrin or other nonsteroidal anti-inflammatory drug or a COX-2 inhibitor eg CelebrexÂ
Detailed Description:
This is a randomized multicenter placebo-controlled double-blind study to evaluate the efficacy and safety of ULTRACET tramadol 375 mg and acetaminophen 325 mg as add-on therapy in rheumatoid arthritis patients taking an NSAID or a COX-2 inhibitor The patients will be randomized into 2 treatment groups The first group will receive one ULTRACET tablet 3 times per day for 7 days The second group will receive one placebo tablet 3 times per day for 7 days The primary efficacy measurement will be the patients average daily pain score Safety will be monitored throughout the study The study hypothesis is that ULTRACET will be well tolerated and the average daily pain relief score for the ULTRACET treatment group will be better than that of placebo group Patients will take one ULTRACET tablet or placebo by mouth 3 times per day for 7 days
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