Acid-Associated Heartburn Symptoms and Dose of Esomeprazole - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206024

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:

MedlinePlus related topics: Heartburn

Drug Information available for: Magnesium Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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

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, Digestive
Signs and Symptoms
Omeprazole
Anti-Ulcer Agents

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012