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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

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ClinicalTrials.gov Identifier: NCT00625274
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : February 28, 2008
Sponsor:
Information provided by:
AstraZeneca

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).

Condition or disease Intervention/treatment Phase
Heartburn Upper Abdominal Pain Nausea Acid Regurgitation Drug: Esomeprazole Drug: Lansoprazole Drug: Pantoprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Oral
Drug: Esomeprazole
40mg Oral
Other Name: Nexium
Experimental: 2
Oral
Drug: Lansoprazole
30mg Oral
Other Name: Prevacid
Experimental: 3
Oral
Drug: Pantoprazole
40mg Oral
Other Name: Protonix



Primary Outcome Measures :
  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 [ Time Frame: Screening, assessments every 2 weeks. ]

Secondary Outcome Measures :
  1. To compare nocturnal intragastric acid control in NSAID-using patients taking esomeprazole 40 mg, lansoprazole 30 mg or pantoprazole 40 mg once daily. [ Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods. ]
  2. 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. [ Time Frame: Patients will be an in-patient beginning the AM of Day 5 through the AM of Day 6 during all three treatment periods. ]
  3. 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. [ Time Frame: 24-hour monitoring period ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625274


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00625274     History of Changes
Other Study ID Numbers: D9612L00063
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008

Keywords provided by AstraZeneca:
Nexium
esomeprazole
lansoprazole
pantoprazole
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Additional relevant MeSH terms:
Abdominal Pain
Heartburn
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Pantoprazole
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents