Nexium Dyspepsia/AST - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00251992

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:

MedlinePlus related topics: Indigestion

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

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):

van Zanten SV, Wahlqvist P, Talley NJ, Halling K, Vakil N, Lauritsen K, Flook N, Persson T, Bolling-Sternevald E; STARS II Investigators. Randomised clinical trial: the burden of illness of uninvestigated dyspepsia before and after treatment with esomeprazole--results from the STARS II study. Aliment Pharmacol Ther. 2011 Oct;34(7):714-23. Epub 2011 Aug 17.

van Zanten SV, Flook N, Talley NJ, Vakil N, Lauritsen K, Bolling-Sternevald E, Persson T, Bjorck E, Svedberg LE; STARS II Study Group. One-week acid suppression trial in uninvestigated dyspepsia patients with epigastric pain or burning to predict response to 8 weeks' treatment with esomeprazole: a randomized, placebo-controlled study. Aliment Pharmacol Ther. 2007 Sep 1;26(5):665-72.

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
Signs and Symptoms
Signs and Symptoms, Digestive
Digestive System Diseases
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012