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Nexium Dyspepsia/AST

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00251992
First Posted: November 11, 2005
Last Update Posted: January 24, 2011
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.
Information provided by:
AstraZeneca
November 9, 2005
November 11, 2005
January 24, 2011
December 2002
January 2005   (Final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT00251992 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Nexium Dyspepsia/AST
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Gastrointestinal Disease
  • Signs and Symptoms, Digestive
  • Dyspepsia
Drug: Esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
January 2005
January 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Finland,   France,   Germany,   Hungary,   Mexico,   Norway,   South Africa,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00251992
SD-NED-0022
D9610C00022
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP