Evaluation of clinical endpoints for treatment-induced changes in GERD-related symptoms - CONQUEST

Phase 1

• Conditions: gastroesophageal reflux disease (GERD)orNon Erosive Reflux Disease (NERD); MedDRA version: 8.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease

• Registration Number: EUCTR2006-004882-32-NL
• Lead Sponsor: ALTANA Pharma bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-20
• Study Completion: 2009-03-13
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
· clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation, as assessed by the investigator
· pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
· any medication for the purpose of the eradication of Helicobacter pylori within the last 28 days prior to B0
· systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days within the last 28 days prior to B0, with the exception of acetylsalicylic acid not more than 150 mg per day

· dyspepsia-inducing drugs for more than 3 consecutive days within the last 7 days prior to B0
· use of any other non-allowed drug
· wash-out times of non-allowed drugs cannot be adhered to
· participation in another study within 30 days preceding visit B0 and during the present study
· previous enrolment into the treatment period of the current study
· patients who are expected to be non-compliant and or non-cooperative or who not able to follow the procedures of the study due to for instance language problems or psychological disorders

Concomitant medication
The use of the following medication is not allowed:

· PPIs, with the exception of the study medication, H2-receptor antagonists, prokinetics, sulcralfate, bismuth preparations or any other substance that may have an influence on the relief of acid-related symptoms, with the exception of antacids
· Any medication for the purpose of the eradication of H. pylori
· Systemic glucocorticosteroids, NSAIDs or COX-2 inhibitors for more than 3 consecutive days, with the exception of acetylsalicylic acid less than 150 mg per day
· Ketoconazole or any other drug with pH-dependent absorption
· dyspepsia-inducing drugs for more than 3 consecutive days

Study & Design

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