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Nexium Dyspepsia/AST

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251992
First received: November 9, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.


Condition Intervention Phase
Gastrointestinal Disease
Signs and Symptoms, Digestive
Dyspepsia
 Drug: Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Supportive Test for Acid-Related Symptoms (STARS II) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Uninvestigated Subjects With Upper Gastrointestinal Symptoms.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
  • The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
  • The patient will judge their symptoms of pain or burning centered in the upper abdomen on a four-graded scale (none, mild, moderate or severe).

Secondary Outcome Measures:
  • The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
  • The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
  • Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy

Estimated Enrollment: 1200
Study Start Date: December 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
  • Helicobacter pylori test performed at enrollment must be negative (Helicobacter pylori is a bacterial infection of the stomach).

Exclusion Criteria:

  • Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD).
  • Helicobacter pylori eradication treatment during the last 12 months prior to enrollment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251992

  Show 182 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00251992     History of Changes
Other Study ID Numbers: SD-NED-0022, D9610C00022
Study First Received: November 9, 2005
Last Updated: January 21, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dyspepsia
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013