ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Completed · Phase 3 · Has a placebo group

Conditions studied: Dyspepsia, Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT01980095

Run by

RedHill Biopharma Limited

People needed

119

Starts

2013-11-01

Expected to finish

2015-08-01

Last updated by the study team

2019-09-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥18 years of age and ≤ 65 years
• 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)
• Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test
• 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)

You may not qualify if…

• Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)
• Have taken antibiotics in the 4 weeks prior to screening
• Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening
• Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer
• Have a history of gastric outlet obstruction
• Have a history of hypersecretory state such as Zollinger-Ellison Syndrome
• Have a history of gastric cancer
• Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Catalina Research Institute — Chino, California, United States
• Jupiter Research, Inc. — Jupiter, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• MedPharmics — Metairie, Louisiana, United States
• Investigative Clinical Research — Annapolis, Maryland, United States
• MGG Group Co. Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• Office of Dr. Stephen Miller, MD — Las Vegas, Nevada, United States
• Peters Medical Research — High Point, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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