Gastro-oesophageal reflux disease MedDRA version: 5.0 Level: llt Classification code 10038263
Conditions
Interventions
Trade Name: Protium 20 mg
Product Name: Protium 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazole
CAS Number: 164579-3
Sponsors
ALTANA Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the performance characteristics of ReQuest™ in Practice with doctors’ ordinary clinical judgement in the stepped down management of GORD;Secondary Objective: ; Primary end point(s): Primary variable: GORD symptom score of ReQuest™ in Practice after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved as assessed by the GORD symptom score of ReQuest™ in Practice after 16 weeks of treatment. The GORD symptom score of ReQuest™ in Practice will be calculated as the sum of the scores for acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea | — |
Countries
United Kingdom
Outcome results
None listed