Efficacy and safety of PANtoprazole in the treatment and SympTom relief in patients with gAstRoesophageal reflux disease (GERD) – PAN-STAR
- Conditions
- gastroesophageal reflux disease (GERD)MedDRA version: 12.1Level: LLTClassification code 10066874Term: Gastroesophageal reflux disease
- Registration Number
- EUCTR2009-017229-20-PL
- Lead Sponsor
- KRKA-POLSKA Sp. z o.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
– Patients of both genders at the age over 18
– Patients with typical GERD symptoms (heartburn/or regurgitation)
– Signed informed consent
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
– Patients with esophageal or gastric malignancies
– Patients with a terminal condition
– Patients with renal impairment (serum creatinine > 300 µmol/l)
– Pregnancy and breast-feeding
– Patients positive for Helicobacter pylori infection
– Patients with GERD symptoms who have been unsuccessfully treated with proton pump inhibitors during a period of 6 months prior to inclusion
– Patients with Barretts’ esophagus
– Patients with evidence of dysplasia
– Patients with active ulcer disease (gastric, duodenal)
– Patients who have been treated with a proton pump inhibitor 30 days or less prior to the first visit
– Hypersensitivity to pantoprazole
– Patients taking any medicine that should influence the results of the treatment
– Patients not able out of any reason to make decisions about participation in the study or not able to fulfill the requirements of the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method