DyspepsiaPhase 3ERADICATE HpNCT01980095
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
A Phase 3 study testing RHB-105 in people with Dyspepsia and Helicobacter Pylori Infection, run by RedHill Biopharma Limited at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- RHB-105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Anaheim Clinical Trials
Anaheim, California, 92801
Investigative Clinical Research
Annapolis, Maryland, 41401
MGG Group Co. Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Catalina Research Institute
Chino, California, 91710
Columbus Regional Research Institute
Columbus, Georgia, 31904
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Peters Medical Research
High Point, North Carolina, 27262
Jupiter Research, Inc.
Jupiter, Florida, 33458
Office of Dr. Stephen Miller, MD
Las Vegas, Nevada, 89144
MedPharmics
Metairie, Louisiana, 70006
Wake Research Associates
Raleigh, North Carolina, 27612
About this study
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
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.
Read the 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 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.
- Conditions
- Dyspepsia, Helicobacter Pylori Infection
- Being tested
- RHB-105, Placebo
- Keywords
- Helicobacter pylori, H. pylori, Dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHB-105Drug
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.
PlaceboDrug
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RHB-105 |
| Placebo | Placebo comparator | Capsules that look like the RHB-105 product but contain no active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28-56 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedHill Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Y Graham, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980095
- Sponsor's protocol ID
- RHB-105-01
- Acronym
- ERADICATE Hp
- Status last verified
- Sep 2019
- First submitted
- 4 Nov 2013
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34862940
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01980095
- Acronym / sponsor ID
- ERADICATE Hp / RHB-105-01
- Conditions
- Dyspepsia, Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, H. pylori, Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- RedHill Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHB-105 | Experimental | Drug: RHB-105RHB-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 | Drug: PlaceboCapsules that look like the RHB-105 product but contain no active ingredient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHB-105The 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. | Drug | RHB-105 |
| PlaceboSubjects will take 4 placebo capsules every 8 hours with food for 14 days. | Drug | Placebo |
Primary outcome
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing
Time frame: 28-56 days after completion of treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34862940Howden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Y Graham, MD principal investigator
Baylor College of Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RHB-105 in people with Dyspepsia and Helicobacter Pylori Infection, run by RedHill Biopharma Limited at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing (time frame: 28-56 days after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.