Gastroenterology (Duodenal Ulcer) , Phase III study

Details

This is a multicentre, randomized, double-blind, prospective, placebo controlled, three arm, parallel group comparison trial, evaluating the clinical bioequivalence of generic sucralfate oral suspension, 1g/10 mL with Carafate® suspension in patients with duodenal ulcer. The primary endpoint is the percentage of patients with endoscopically assessed DU healing after 56 ± 2 days of treatment (approximately 8 weeks); the secondary endpoints include percentage of patients with endoscopically assessed DU healing after 28 ± 2 days of treatment (approximately 4 Weeks), the use of antacid rescue medication, ulcer pain scores and occurrence of adverse events. Total sample size: 575

Inclusion Criteria

Patients meeting all of the following criteria can be enrolled: 1. Patients of ≥18 and ≤65 years of age 2. Patient must have endoscopically confirmed active duodenal ulcer of at least 3 mm in diameter and not exceeding 25 mm. Patients may have up to a maximum of two duodenal ulcers 3. Patients must be confirmed H.pylorinegative. Absence of H.pyloriwill be confirmed by rapid urease test and microbiology. Patients can be enrolled if found to be H.pylorinegative by rapid urease test performed locally. However, final confirmation will be done by biopsy specimen culture and histology at the central laboratory. The central laboratory result will be considered as final and if a patient is found to be H.pyloripositive, then he/she will be withdrawn from the study. Patient Pool: 25 patients needed from one site.

Further information

Site should have registered Ethics Committee with DCG(I) and should have endoscopy facility along with ICH GCP Trained staff.

Contact

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