| February 27, 2008 |
| March 12, 2009 |
| March 2001 |
| December 2002 (final data collection date for primary outcome measure) |
| To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ] |
| Same as current |
| Complete list of historical versions of study NCT00629512 on ClinicalTrials.gov Archive Site |
- Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
- Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
|
| Same as current |
| |
| Prevention of Gastric Ulcers |
| A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk |
Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk. |
| |
| Phase III |
| Interventional |
| Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| NSAID Associated Gastric Ulcers |
- Drug: Esomeprazole
- Drug: Placebo
|
- Experimental: 20mg oral daily
- Experimental: 40mg oral daily
|
| |
| |
| Completed |
| 504 |
| December 2002 |
| December 2002 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- No gastric or duodenal ulcer on baseline endoscopy.
- A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
- Other inclusion criteria, as defined in the protocol.
Exclusion Criteria:
- History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- Other criteria, as defined in the protocol.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00629512 |
|
| SH-NEN-0013 |
| AstraZeneca |
|
| Principal Investigator: |
Professor Chris Hawkey |
Queens Medical Centre |
|
| Study Director: |
Paula Fernstrom |
Nexium Global Product Director, AstraZeneca |
|
|
| AstraZeneca |
| March 2009 |