Status:
COMPLETED
A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients
Lead Sponsor:
AstraZeneca
Conditions:
Heartburn
Upper Abdominal Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study looks at controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selecti...
Eligibility Criteria
Inclusion
- A medical diagnosis of a condition that requires daily Nonsteroidal Anti-Inflammatory Drugs (NSAID) treatment for at least 5 days per week for 1 month prior to entering the study and during the study.
- Some patients will need to undergo an upper endoscopy at screening.
Exclusion
- Signs of clinically significant (GI) bleeding (e.g., melena, frank hematochezia) at the time of the baseline EGD or within 3 days prior to randomization.
- History of gastric or esophageal surgery (including but not limited to Nissen fundoplication, bariatric surgery (e.g. gastric stapling or Roux-En-Y gastric bypass), vagotomy, or Billroth operation).
- Many further exclusion criteria, please refer to the investigator site.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00625274
Start Date
June 1 2004
End Date
November 1 2004
Last Update
February 28 2008
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