A Phase 3 interventional study of RHB-105 and Placebo in Dyspepsia and Helicobacter Pylori Infection, sponsored by RedHill Biopharma Limited. Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-24.
Sponsored by RedHill Biopharma Limited · Phase 3, Interventional, and Treatment
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.
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 1:2 between placebo arm (n=30) and the active arm (RHB-105) (n=60). 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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 119 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →RedHill Biopharma Limited is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.
Drug: RHB-105
Capsules that look like the RHB-105 product but contain no active ingredient.
Drug: Placebo
The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg Subjects will take study drug every 8 hours with food for 14 consecutive days.
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing
Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.
Time frame: 28-56 days after completion of treatment
H. Pylori Eradication
The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment
Time frame: 28-56 days after completion of SOC treatment
| Milestone | RHB-105 | Placebo |
|---|---|---|
| Started | 78 | 41 |
| Treated | 77 | 41 |
| Completed | 63 | 30 |
| Not completed | 15 | 11 |
| Withdrew: Lost to follow-up | 6 | 7 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Poor compliance | 5 | 0 |
| Withdrew: Safety issue | 0 | 1 |
| Withdrew: Study drug discontinued | 1 | 0 |
| Withdrew: Randomized by mistake | 1 | 0 |
Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.
| Participants | RHB-105 | Placebo |
|---|---|---|
| H. pylori eradication success | 59 | 1 |
| H. pylori eradication failure | 7 | 36 |
The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment
| Participants | Placebo Subjects | Active Drug Eradication Failure Subjects |
|---|---|---|
| H. pylori eradication success | 17 | 2 |
| H. pylori eradication failure | 10 | 2 |
Collected over 1 year and 10 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RHB-105 | — | 1/77 (1.3%) | 38/77 (49.4%) |
| Placebo | — | 1/41 (2.4%) | 17/41 (41.5%) |
| Event | RHB-105 | Placebo |
|---|---|---|
| Perirectal AbscessSkin and subcutaneous tissue disorders | 0/77 | 1/41 |
| Anemia of Grade 3Blood and lymphatic system disorders | 1/77 | 0/41 |
| Event | RHB-105 | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 11/77 | 4/41 |
| HeadacheNervous system disorders | 10/77 | 4/41 |
| ChromaturiaRenal and urinary disorders | 10/77 | 1/41 |
| Abdominal tendernessGastrointestinal disorders | 5/77 | 3/41 |
| FlatulenceGastrointestinal disorders | 2/77 | 3/41 |
| DizzinessNervous system disorders | 3/77 | 3/41 |
| Age, Continuous(years) | RHB-105 | Placebo | Total |
|---|---|---|---|
| Mean | 46.2 ± 10.56 | 45.8 ± 9.52 | 46 ± 10.18 |
| Sex: Female, Male(Participants) | RHB-105 | Placebo | Total |
|---|---|---|---|
| Female | 28 | 16 | 44 |
| Male | 49 | 25 | 74 |
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RedHill Biopharma Limited