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OpenTrials
Completed

NCT Number: NCT00251914

Nexium Dyspepsia/AST

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.

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Key information

Conditions

Gastrointestinal Disease Digestive System Diseases Dyspepsia Gastrointestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole

Drug

Primary outcomes

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

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

  3. 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 outcomes

  1. The secondary efficacy outcomes are whether the patient is a responder or not after 4 weeks,

  2. The average symptom score and the percentage of symptom-free days during the 7-week treatment period,

  3. Presence/absence of specific GI symptoms after 4 and 8 weeks of therapy

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Nov 11, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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