Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01980095
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2013-11-04
Brief Title:
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Sponsor:
RedHill Biopharma Limited
Organization:
RedHill Biopharma Limited
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase 3 Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori H Pylori Infection in Non-investigated Dyspepsia Patients
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERADICATE Hp
Brief 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
Detailed Description:
This is a randomized double-blind placebo-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H pylori infection via 13C Urea Breath Test UBT and either fecal antigen test or CLO test
Eligible subjects will be randomized in a ratio of 12 between placebo arm n30 and the active arm RHB-105 n60 Subjects will receive study drug for 14 consecutive days Eradication of H pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy
Subjects will be unblinded upon 13C UBT analysis This will provide timely active therapy to all subjects enrolled in this study Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding
Eradication failures 13C UBT-positive in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing to rifabutin amoxicillin clarithromycin and metronidazole Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects
Eligible subjects will be randomized in a ratio of 12 between placebo arm n30 and the active arm RHB-105 n60 Subjects will receive study drug for 14 consecutive days Eradication of H pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy
Subjects will be unblinded upon 13C UBT analysis This will provide timely active therapy to all subjects enrolled in this study Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding
Eradication failures 13C UBT-positive in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing to rifabutin amoxicillin clarithromycin and metronidazole Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None