Open, Randomised, Multi-center Study of on Demand Versus Continuous Esomeprazole Treatment in Patient With GERD

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months.

• Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or, if PPI treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of PPI treatment

• Male or female, at least 18 years of age (for Austria, at least 19 years of age)

• Have given written informed consent

• Ability to read and write (literate)

• 7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)

Exclusion Criteria:

• Documented esophageal mucosal break

• History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer

• Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria:

• Symptoms relieved by defecation

• Symptoms associated with change in frequency of stools

• Symptoms associated with change in form of stools

• Any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.

• Subjects with current or historical evidence of the following diseases/conditions

• Zollinger Ellison syndrome

• Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm

• Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus

• Evidence of upper gastrointestinal malignancy at the screening endoscopy

• Gastric and/or duodenal ulcers within the last 2 years

• Malabsorption

• Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator

• Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable

• Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus

• Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy

• Use of PPIs for more than 5 days in the last 7 days prior to endoscopy

• Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study

• Need for continuous concurrent therapy with

• NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily for cardiovascular prophylaxis)

• anticholinergics

• prostaglandin analogues

• phenytoin

• ketoconazole

• itraconazole

• warfarin and other vitamin K antagonists

• Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For South-Africa and Spain:

Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)

• Use of any other investigational compound 28 days prior to start and during the study

• Requirement of an interpreter (illiterate)

• Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator

• Previous participation in this study

• Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole