Nexium Dyspepsia/AST

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00251992
• Date of registration: 09/11/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Nexium Dyspepsia/AST
• Scientific 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.
• Date of first enrolment: December 2002
• Target sample size: 1200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00251992
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Canada, Finland, France, Germany, Hungary, Mexico, Norway, South Africa, Sweden, Switzerland, United Kingdom

Contacts

• Name: AstraZeneca Nexium Medical Sciences Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Signs and Symptoms, Digestive

Dyspepsia

Gastrointestinal Disease

Intervention(s)

Drug: Esomeprazole

Primary Outcome(s)

The primary efficacy outcome is based on symptom score recorded daily during the study in a patient diary.

The primary outcome is whether the patient is a responder or not after 8 weeks treatment.

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(s)

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

Secondary ID(s)

SD-NED-0022

D9610C00022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors