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

Study Overview
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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).

Conditions
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Heartburn, Upper Abdominal Pain, Nausea, Acid Regurgitation

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Lansoprazole
* Drug: Pantoprazole


Participation Criteria
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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). Many further exclusion criteria, please refer to the investigator site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral | Drug: Esomeprazole<br>* 40mg Oral<br>* Other names: Nexium;|
| Experimental: 2<br>Oral | Drug: Lansoprazole<br>* 30mg Oral<br>* Other names: Prevacid;|
| Experimental: 3<br>Oral | Drug: Pantoprazole<br>* 40mg Oral<br>* Other names: Protonix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Screening, assessments every 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nexium, esomeprazole, lansoprazole, pantoprazole, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)