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
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation
Intervention: Esomeprazole (Drug); Lansoprazole (Drug); Pantoprazole (Drug)
Phase: Phase 4
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacodynamics Study
Primary outcome: To compare the pharmacodynamic efficacy in controlling intragastric pH (percent time pH > 4.0) following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in pat
To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily.
To compare intragastric acid control utilizing thresholds other than pH 4.0 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg once daily.
To compare the mean hourly cumulative integrated gastric acidity during the 24-hour monitoring period on Day 5 among NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30mg and pantoprazole 40 mg once daily.
Minimum age: 18 Years.
Maximum age: 60 Years.
- 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.
- 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.
Locations and Contacts
Starting date: June 2004
Ending date: November 2004
Last updated: February 27, 2008