Nexium Dyspepsia/AST

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251992
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : January 24, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Gastrointestinal Disease Signs and Symptoms, Digestive Dyspepsia Drug: Esomeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : December 2002
Primary Completion Date : January 2005
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary outcome is whether the patient is a responder or not after 8 weeks treatment.
  2. The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.
  3. 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 :
  1. The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,
  2. The average symptom score and the percentage of symptom-free days during the 7-week treatment period,
  3. Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251992

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00251992     History of Changes
Other Study ID Numbers: SD-NED-0022
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action