ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RedHill Biopharma Limited

Criteria

Inclusion Criteria:

1. Be ≥18 years of age and ≤ 65 years

2. Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals)

3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test

4. Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent)

Exclusion Criteria:

1. Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)

2. Have taken antibiotics in the 4 weeks prior to screening

3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening

4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer

5. Have a history of gastric outlet obstruction

6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome

7. Have a history of gastric cancer

8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers