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NCT Number: NCT00206024

Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

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.

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole magnesium (Nexium)

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium

Important dates

Study start
2004
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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