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Nexium Dyspepsia/AST

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Gastrointestinal Disease
Signs and Symptoms, Digestive
Dyspepsia

Treatments

Drug: Esomeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00251914
D9610C00021
SD-NED-0021

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

217

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Data sourced from clinicaltrials.gov

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