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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00206024
Collaborator
(none)
330
Enrollment
27
Locations
8
Duration (Months)
12.2
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Esomeprazole magnesium (Nexium)
 Phase 4

Study Design

Study Type:
Interventional
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 :
Nov 1, 2004
Actual Study Completion Date :
Jul 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

    1. 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

Locations

Site City State Country Postal Code
1 Research Site Tucson Arizona United States
2 Research Site Anaheim California United States
3 Research Site Orange California United States
4 Research Site San Diego California United States
5 Research Site Washington District of Columbia United States
6 Research Site DeLand Florida United States
7 Research Site Miami Florida United States
8 Research Site New Smyrna Beach Florida United States
9 Research Site Tampa Florida United States
10 Research Site Zephyrhills Florida United States
11 Research Site Atlanta Georgia United States
12 Research Site Chicago Illinois United States
13 Research Site New Orleans Louisiana United States
14 Research Site Annapolis Maryland United States
15 Research Site Baltimore Maryland United States
16 Research Site Hollywood Maryland United States
17 Research Site Attleboro Massachusetts United States
18 Research Site Hackensack New Jersey United States
19 Research Site Vineland New Jersey United States
20 Research Site Rochester New York United States
21 Research Site Asheville North Carolina United States
22 Research Site Elkin North Carolina United States
23 Research Site Guthrie Oklahoma United States
24 Research Site Philadelphia Pennsylvania United States
25 Research Site Knoxville Tennessee United States
26 Research Site Christiansburg Virginia United States
27 Research Site Ponce Puerto Rico

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Nexium Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00206024
Other Study ID Numbers:
  • D9612L00064
First Posted:
Sep 21, 2005
Last Update Posted:
Nov 19, 2010
Last Verified:
Nov 1, 2010
Additional relevant MeSH terms:
Heartburn
Esomeprazole

Study Results

No Results Posted as of Nov 19, 2010