Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHB-105 | Experimental | 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. |
|
| Placebo | Placebo Comparator | Capsules that look like the RHB-105 product but contain no active ingredient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHB-105 | Drug | 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:
Subjects will take study drug every 8 hours with food for 14 consecutive days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28-56 days after completion of treatment |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| H. Pylori Eradication | The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment | 28-56 days after completion of SOC treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Y Graham, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Anaheim Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34862940 | Derived | Howden CW, Sheldon KL, Almenoff JS, Chey WD. Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. Dig Dis Sci. 2022 Sep;67(9):4382-4386. doi: 10.1007/s10620-021-07323-5. Epub 2021 Dec 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RHB-105 | 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. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Subjects will take 4 placebo capsules every 8 hours with food for 14 days. |
|
| Anaheim |
| California |
| 92801 |
| United States |
| Catalina Research Institute | Chino | California | 91710 | United States |
| Jupiter Research, Inc. | Jupiter | Florida | 33458 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| MedPharmics | Metairie | Louisiana | 70006 | United States |
| Investigative Clinical Research | Annapolis | Maryland | 41401 | United States |
| MGG Group Co. Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | United States |
| Office of Dr. Stephen Miller, MD | Las Vegas | Nevada | 89144 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
Capsules that look like the RHB-105 product but contain no active ingredient. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RHB-105 | 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. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg. |
| BG001 | Placebo | Capsules that look like the RHB-105 product but contain no active ingredient. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The mITT Population included all subjects who received at least 1 dose of randomized study treatment and underwent a 13C UBT test at Visit 4. This population consisted in 66 subjects in the RHB-105 group and 37 subjects in the placebo group. | Posted | Count of Participants | Participants | 28-56 days after completion of treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | H. Pylori Eradication | The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment | Eradication Failure Subjects at Visit 4 were treated with standard of care therapy by the investigator and performed a 13C Urea Breath Test at Visit 8 to confirm H. pylori eradication. This population included 27 subjects in the placebo group and 4 subjects in the active drug eradication failure subjects. | Posted | Count of Participants | Participants | 28-56 days after completion of SOC treatment |
|
|
1 year and 10 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RHB-105 | 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. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg. | 1 | 77 | 38 | 77 | ||
| EG001 | Placebo | Identical capsules that look like the RHB-105 product but contain no active ingredient. | 1 | 41 | 17 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia of Grade 3 | Blood and lymphatic system disorders | MedDRA (16.0) |
| ||
| Perirectal Abscess | Skin and subcutaneous tissue disorders | MedDRA (16.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) |
| ||
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (16.0) |
| ||
| Flatulence | Gastrointestinal disorders | MedDRA (16.0) |
| ||
| Headache | Nervous system disorders | MedDRA (16.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (16.0) |
| ||
| Chromaturia | Renal and urinary disorders | MedDRA (16.0) |
|
The PI agree that the Sponsor shall have the right to the first publication of the results of the Study. Following the first publication, the PI may publish data or results from the Study; subject to Sponsor for review and approval in writing at least sixty (60) days prior to the date of the publication. Sponsor may require changes and may extend the embargo to protect its intellectual property or other proprietary interests and to allow for the taking actions for this purpose.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ira Kalfus | RedHill Biopharma | 1-917-817-7517 | ira@redhillbio.com |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
|