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

Phase 4

Completed

• Conditions: Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation
• Interventions: Drug: Esomeprazole; Drug: Lansoprazole; Drug: Pantoprazole

• Registration Number: NCT00625274
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Status Verified: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-27
• Last Update Submitted: 2008-02-27
• Study First Posted: 2008-02-28
• Last Update Posted: 2008-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	Oral
2	Lansoprazole	Oral
3	Pantoprazole	Oral

Primary Outcome Measures

Name	Time	Method
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	Screening, assessments every 2 weeks.

Secondary Outcome Measures

Name	Time	Method
To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily.	Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
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.	Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods.
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.	24-hour monitoring period