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

NCT00625274 | Completed Phase 4

• 1 other identifier: D9612L00063
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

Oral

Drug: Esomeprazole

2

EXPERIMENTAL

Oral

Drug: Lansoprazole

3

EXPERIMENTAL

Oral

Drug: Pantoprazole

Interventions

Esomeprazole DRUG

40mg Oral

Also known as: Nexium

1

Lansoprazole DRUG

30mg Oral

Also known as: Prevacid

2

Pantoprazole DRUG

40mg Oral

Also known as: Protonix

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Heartburn; Abdominal Pain; Nausea

Interventions

Esomeprazole; Lansoprazole; Pantoprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 28, 2008
• Study Start: June 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: February 28, 2008

Record last verified: 2008-02