Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206024
First received: September 12, 2005
Last updated: November 18, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Heartburn
Drug: Esomeprazole magnesium (Nexium)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 330
Study Start Date: November 2004
Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206024

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

No publications provided

ClinicalTrials.gov Identifier: NCT00206024     History of Changes
Other Study ID Numbers: D9612L00064
Study First Received: September 12, 2005
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014