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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

NCT ID: NCT00625274

Last Updated: 2008-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2004-11-30

Brief Summary

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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

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Conditions

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Heartburn Upper Abdominal Pain Nausea Acid Regurgitation

Keywords

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Nexium esomeprazole lansoprazole pantoprazole Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg Oral

2

Oral

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type DRUG

30mg Oral

3

Oral

Group Type EXPERIMENTAL

Pantoprazole

Intervention Type DRUG

40mg Oral

Interventions

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Esomeprazole

40mg Oral

Intervention Type DRUG

Lansoprazole

30mg Oral

Intervention Type DRUG

Pantoprazole

40mg Oral

Intervention Type DRUG

Other Intervention Names

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Nexium Prevacid Protonix

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Paula Fernstrom

Role: STUDY_DIRECTOR

Nexium Global Product Director, AstraZeneca

Other Identifiers

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D9612L00063

Identifier Type: -

Identifier Source: org_study_id