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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

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ClinicalTrials.gov Identifier: NCT00206024
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Condition or disease Intervention/treatment Phase
Heartburn Drug: Esomeprazole magnesium (Nexium) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
Study Start Date : November 2004
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn




Primary Outcome Measures :
  1. Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".

Secondary Outcome Measures :
  1. Relief of heartburn during the 4th week of treatment
  2. Cumulative daily sustained resolution rate through 4 weeks of treatment
  3. Time to first day of the first 7-day period of sustained resolution of heartburn
  4. Time to the first day of the first 7-day period of relief of heartburn
  5. Percentage of subject-reported heartburn-free days through 4 weeks of treatment
  6. Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
  7. Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
  • A history of heartburn for at least 6 months
  • A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
  • A positive esophageal acid perfusion test
  • At least 3 days of 'moderate' severity heartburn over the previous 7 days
  • No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

Exclusion Criteria:

  • A history of gastric or esophageal surgery
  • H. pylori positive
  • A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
  • Currently taking higher than the standard approved proton pump inhibitor doses
  • Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.

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): NCT00206024


Locations
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United States, Arizona
Research Site
Tucson, Arizona, United States
United States, California
Research Site
Anaheim, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
DeLand, Florida, United States
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Miami, Florida, United States
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New Smyrna Beach, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Zephyrhills, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Maryland
Research Site
Annapolis, Maryland, United States
Research Site
Baltimore, Maryland, United States
Research Site
Hollywood, Maryland, United States
United States, Massachusetts
Research Site
Attleboro, Massachusetts, United States
United States, New Jersey
Research Site
Hackensack, New Jersey, United States
Research Site
Vineland, New Jersey, United States
United States, New York
Research Site
Rochester, New York, United States
United States, North Carolina
Research Site
Asheville, North Carolina, United States
Research Site
Elkin, North Carolina, United States
United States, Oklahoma
Research Site
Guthrie, Oklahoma, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States
United States, Virginia
Research Site
Christiansburg, Virginia, United States
Puerto Rico
Research Site
Ponce, Puerto Rico
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Nexium Medical Science Director, MD AstraZeneca
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ClinicalTrials.gov Identifier: NCT00206024    
Other Study ID Numbers: D9612L00064
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Heartburn
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action