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
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | Heartburn Upper Abdominal Pain Nausea Acid Regurgitation |
Intervention | Drug: Esomeprazole Drug: Lansoprazole Drug: Pantoprazole |
Phase | Phase 4 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00625274 |
First Received | February 20, 2008 |
Last Updated | February 27, 2008 |
Last verified | February 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | February 20, 2008 |
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Last Updated Date | February 27, 2008 |
Start Date | June 2004 |
Estimated Primary Completion Date | November 2004 |
Current Primary Outcome Measures | 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.] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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Official Title | Not Provided |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Esomeprazole 40mg Oral Other Names: NexiumDrug: Lansoprazole 30mg Oral Other Names: PrevacidDrug: Pantoprazole 40mg Oral Other Names: Protonix |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 100 |
Estimated Completion Date | November 2004 |
Estimated Primary Completion Date | November 2004 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00625274 |
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Other Study ID Numbers | D9612L00063 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca |
Verification Date | February 2008 |