Nexium Dyspepsia/AST

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: November 9, 2005
Last updated: January 21, 2011
Last verified: January 2011

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
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 I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.

Resource links provided by NLM:

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: 1500
Study Start Date: December 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment.
  • Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach)

Exclusion Criteria:

  • Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment.
  • 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.
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Please refer to this study by its identifier: NCT00251914

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Sponsors and Collaborators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00251914     History of Changes
Other Study ID Numbers: SD-NED-0021, D9610C00021
Study First Received: November 9, 2005
Last Updated: January 21, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on March 30, 2015