Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175032
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2005-09-12
Brief Title:
A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taking Low Dose Aspirin
Status:
COMPLETED
Status Verified Date:
2010-07
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:
The purpose of this study is to compare the gastroduodenal ulceration rate gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole naproxen and celecoxib taken once daily QD or twice daily BID in participants with osteoarthritis taking low dose aspirin
Detailed Description:
This study was designed to compare the effectiveness of reducing the incidence of gastroduodenal ulcers between lansoprazole 30mg QD naproxen 500mg BID vs celecoxib 200mg QD in subjects with osteoarthritis taking low dose aspirin Approximately 100 sites across the US will enroll subjects with normal endoscopic findings and negative Hpylori The duration of the study will be a maximum of 14 weeks including a screening period of up to 2 weeks and a 12 week treatment period Gelusil will be provided for dyspepsia symptom rescue
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-2275 | REGISTRY | WHO | None |