EUCTR2006-004882-32-NL
Active, not recruiting
Phase 1
Evaluation of clinical endpoints for treatment-induced changes in GERD-related symptoms - CONQUEST
ALTANA Pharma bv0 sites0 target enrollmentOctober 20, 2006
Conditionsgastroesophageal reflux disease (GERD)orNon Erosive Reflux Disease (NERD)MedDRA version: 8.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease
DrugsPantozol 40mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- gastroesophageal reflux disease (GERD)orNon Erosive Reflux Disease (NERD)
- Sponsor
- ALTANA Pharma bv
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Written informed consent
- •· Aged at least 18 years
- •· History of GERD\-related symptoms of at least 6 months prior to B0
- •· Heartburn on at least 3 days within the last 7 days prior to B0 as assessed by the investigator
- •· Acid complaints on at least 3 days within the last 7 days prior to B0 as assessed by the investigator
- •· Endoscopically confirmed GERD A \- D classification determined via the Los Angeles classification system or symptom\-based diagnosis of NERD
- •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
Exclusion Criteria
- •· Zollinger\-Ellison syndrome or any other gastric hypersecretory condition
- •· previous acid\-lowering surgery or any other surgery of the oesophagus and / or upper gastrointestinal tract, with the exception of polyectomy and cholecystectomy
- •· presence of obstructive oesophageal strictures, Schatzki’s ring, oesophageal diverticula, oesophageal varices, achalasia or Barrett’s oesophagus with known high\-grade dysplasia or longer than 3 cm
- •· acute peptic ulcer and / or ulcer complications
- •· pyloric stenosis
- •· inflammatory bowel diseases
- •· severe or unstable cardiovascular, pulmonary and / or endocrine disease, clinically significant renal or hepatic disease or dysfunction, haematological disorder, severe psychiatric or neurological disorders or any other clinically significant condition
- •· malignancy of any kind within 5 years prior to B0, with the exception of successfully treated basal or squamous cell cancer of the skin
- •· known or suspected hypersensitivity to the study medication
- •· known or suspected alcohol or drug abuse within 1 year prior to B0
Outcomes
Primary Outcomes
Not specified
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