Nexium Dyspepsia/AST

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251914

Enrollment

1500

Registered

2005-11-11

Start date

2002-12-31

Completion date

2005-01-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Gastrointestinal Disease, Signs and Symptoms, Digestive

Brief summary

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.

Interventions

DRUGEsomeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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).	—
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.	—

Secondary

Measure	Time frame
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	—

Countries

Argentina, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Iceland, Italy, Norway, Romania, Singapore, South Africa, Spain, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026