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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type : Interventional  (Clinical Trial)
Estimated 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
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heartburn
U.S. FDA Resources




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, Senior)
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


  Show 27 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nexium Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00206024     History of Changes
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:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action