Determination of the performance characteristics of ReQuestTM in Practice in the stepped down management of GORD - PRISM

Phase 1

Active, not recruiting

• Conditions: Gastro-oesophageal reflux disease; MedDRA version: 5.0 Level: llt Classification code 10038263

• Registration Number: EUCTR2005-000711-10-GB
• Lead Sponsor: ALTANA Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-27
• Study Completion: 2006-03-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

- Written informed consent by the patient for study participation, prior to protocol specific procedures
- Outpatients of at least 18 years of age
- GORD
- Patients with symptoms the doctor believes to be due to GORD and which warrant in his view treatment with proton pump inhibitors

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Signs, indicating other gastrointestinal diseases:
- Zollinger-Ellison syndrome or other gastric hypersecretory condition
- Previous acid-lowering surgery or other surgery of the oesophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy)
- On initial endoscopy, presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett‘s oesophagus with dysplasia or longer than 3 cm
- Acute peptic ulcer and/or ulcer complications
- Inflammatory bowel diseases

Other concomitant diseases:
- Severe or unstable cardiovascular (e.g., severe angina pectoris, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; haematological disorder; any other clinically significant medical condition that could increase the risk to the study participant
- Malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer
- Hypersensitivity to one of the compounds of the study medication
- Alcohol, drug or medication abuse within the past year
- Abnormal laboratory parameters and vital signs considered as clinically relevant by the investigator
- Severe psychiatric or neurological disorders

Special restrictions for female patients:
- Pregnant or nursing female patients
- Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized / hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases

Previous medication:
- PPIs, H2-receptor antagonists or prokinetics during the last 14 days before intake of study medication
- Any medication for the purpose of the eradication of H. pylori during the last 28 days before intake of study medication
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before intake of study medication; except regular intake of acetylsalicylic acid in dosages up to 150 mg/d

Concomitant medication:
- PPIs, (except study medication), H2-receptor antagonists or prokinetics
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) except regular intake of acetylsalicylic acid in dosages up to 150 mg/d
- Ketoconazole or other drugs with pH-dependent absorption
- PPIs in combination with antibiotics for the purpose of the eradication of H. pylori
- Initiation of daily psychotropic medication

Others:
- Patients who are expected to be non-compliant and/or not cooperative
- Participation in a clinical study wi

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified