Nexium Dyspepsia/AST - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00251914

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 II Phase III

MedlinePlus related topics: Indigestion

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

Eligibility

Ages Eligible for Study:	18 Years to 70 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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251914

Show 217 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Nexium Medical Sciences Director, MD

AstraZeneca

More Information

Publications indexed to this study:

Talley NJ, Vakil N, Lauritsen K, van Zanten SV, Flook N, Bolling-Sternevald E, Persson T, Bjorck E, Lind T; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82.

Study ID Numbers:	SD-NED-0021, D9610C00021
Study First Received:	November 9, 2005
Last Updated:	November 9, 2005
ClinicalTrials.gov Identifier:	NCT00251914
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Omeprazole
Dyspepsia

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009