?The effect of acute and chronic administration of the CCK1 receptor antagonist Dexloxiglumide (CR2017) on 24-h pH metry, LES motor and symptoms? pattern, in patients with gastroesophageal reflux disease (GERD). A randomized, double-blind, placebo controlled study? - ND
- Conditions
- gastroesaphageal reflux disease (GERD)MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease
- Registration Number
- EUCTR2007-003478-25-IT
- Lead Sponsor
- ROTTAPHARM / ROTTA RESEARCH LABORATORIUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- males or female - age >=18 and <=70 - patients with the symptoms of gastroesaphageal reflux disease (GERD) - heartburn, gastric burning sensation and regurgitation - according to the following: presence of all the 3 symptoms, regardless of intensity or duration, presence of at least one of the 3 symptoms, with intensity at least moderate or duration at least between 15 and 30 minutes daily - signed informed consent - use of contraceptive methods for women of child-bearing potential
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
- hiatal hernia - abdominal surgery - pregnant or breast-feeding females - significant diseases - use of prohibited medication (among which, H2 blockers and antiacids)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: safety and efficacy of dexloxiglumide after acute (1 day) and chronic (4 weeks) treatment on pH reduction of the esophagus and symptoms improvement in an adult population of both sexes suffering from GERD;Primary end point(s): reduction of number of TLESRs measured during a 24h pH-manometry;Main Objective: efficacy of dexloxiglumide after acute (1 day) and chronic (4 weeks) treatment on the improvement of LES motility in an adult population of both sexes suffering from GERD
- Secondary Outcome Measures
Name Time Method