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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
ClinicalTrials.gov processed this data on August 23, 2015
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

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca

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-selective or cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs).

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Additional Information

Starting date: June 2004
Last updated: February 27, 2008

Page last updated: August 23, 2015

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