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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Heartburn; Nausea; Upper Abdominal Pain; Acid Regurgitation

Treatments: Drug: Esomeprazole; Drug: Lansoprazole; Drug: Pantoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625274

D9612L00063

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

1

Experimental group

Description:

Oral

Treatment:

Drug: Esomeprazole

2

Experimental group

Description:

Oral

Treatment:

Drug: Lansoprazole

3

Experimental group

Description:

Oral

Treatment:

Drug: Pantoprazole