Nexium Dyspepsia/AST

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251914
First received: November 9, 2005
Last updated: January 21, 2011
Last verified: January 2011
  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 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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
Dyspepsia
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on July 24, 2014