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

February 27, 2008 updated by: 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 drugs (NSAIDs).

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Oral
40mg Oral
Other Names:
  • Nexium
Experimental: 2
Oral
30mg Oral
Other Names:
  • Prevacid
Experimental: 3
Oral
40mg Oral
Other Names:
  • Protonix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Screening, assessments every 2 weeks.
Screening, assessments every 2 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

November 1, 2004

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 27, 2008

Last Verified

February 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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