gastroesophageal reflux disease (GERD) MedDRA version: 12.1 Level: LLT Classification code 10066874 Term: Gastroesophageal reflux disease
Conditions
Interventions
Trade Name: Nolpaza
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Pantoprazolum
CAS Number: 164579-32-2
Other descriptive name: PANTOPRAZOLE SODIUM SESQUIHYDRATE
Concentration unit
Sponsors
KRKA-POLSKA Sp. z o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – 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
Exclusion criteria
Exclusion criteria: – 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To establish the efficacy of the treatment with 40 mg of pantoprazole in patients with reflux esophagitis and in those with non-erosive reflux disease (NERD) 2. To establish the effect of the treatment duration on the healing of reflux esophagitis and non-erosive reflux disease (NERD) ;Secondary Objective: 1. To establish the effect of the treatment with pantoprazole 40 mg on the quality of life of patients with reflux esophagitis and in patients with non-erosive reflux disease (NERD) 2. To define the factors influencing acute therapy 3. To quantify the rate of adverse events associated with pantoprazole treatment ;Primary end point(s): 1. To establish the efficacy of the treatment with 40 mg of pantoprazole in patients with reflux esophagitis and in those with non-erosive reflux disease (NERD) 2. To establish the effect of the treatment duration on the healing of reflux esophagitis and non-erosive reflux disease (NERD) | — |
Countries
Poland
Outcome results
None listed