Gastric Ulcer Associated With Helicobacter PyloriNCT01645761
Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
A study testing Endonase in people with Gastric Ulcer Associated With Helicobacter Pylori, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Ulcer Associated With Helicobacter Pylori
- What is being tested?
- Endonase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female with 18 years or more of age without history of H. pylori eradication AND
- Patients with H. pylori associated peptic ulcer in scar stage, OR
- Non-ulcer dyspepsia patients with H. pylori infection
Who cannot join
- Under 18 years, OR
- Patients with a history of previous treatment of H. pylori infection, OR
- Pregnant or Breast feeding women, OR
- Patients with severe renal, liver, or heart disease, OR
- Patients with gastric malignancy, OR
- Patients with a history of drug allergy or hypersensitivity, OR
- Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200-100
About this study
Official title: Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.
- Being tested
- Endonase
- Keywords
- Helicobacter pylori eradication, Peptic ulcer
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndonaseDrug
PPI- based triple therapy with endonase
| Study group | Role | What they receive |
|---|---|---|
| PPI-based triple therapy with endonase | Experimental | 7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week. Receives: Drug: Endonase |
| PPI-based triple therapy | No intervention | 7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy
Measured: 4 weeks
Secondary outcomes (2)
Number of participants with adverse events
Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment
Measured: 4 weeks
Number of participants taking over 85% of medicine
Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Ulcer Associated With Helicobacter PyloriStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeonsoo Kim, Chuncheon Sacred Heart Hospital
- Investigators
- Jin Bong Kim, MD, Study chair, Department of Internal Medicine, Hallym university college of medicineYeon Soo Kim, MD, PhD., Study director, Department of Internal Medicine, Hallym University College of MedicineChang Seok Bang, MD, Principal investigator, Department of Internal Medicine, Hallym University of College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645761
- Sponsor's protocol ID
- CSHH Endonase 1
- Other IDs
- CLDD 1
- Status last verified
- Jan 2014
- First submitted
- 16 Jul 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399.
PubMed 25167799
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01645761
- Acronym / sponsor ID
- CSHH Endonase 1
- Keywords
- Helicobacter pylori eradication, Peptic ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI-based triple therapy with endonase | Experimental | Drug: Endonase7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week. |
| PPI-based triple therapy | No intervention | –7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female with 18 years or more of age without history of H. pylori eradication AND
- Patients with H. pylori associated peptic ulcer in scar stage, OR
- Non-ulcer dyspepsia patients with H. pylori infection
Key exclusion criteria (7 listed)
- Under 18 years, OR
- Patients with a history of previous treatment of H. pylori infection, OR
- Pregnant or Breast feeding women, OR
- Patients with severe renal, liver, or heart disease, OR
- Patients with gastric malignancy, OR
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 |
|---|---|---|
| EndonasePPI- based triple therapy with endonase | Drug | PPI-based triple therapy with endonase |
Primary outcome
Eradication rate
Time frame: 4 weeks
Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy
2 secondary outcomes
Number of participants with adverse events
Time frame: 4 weeks
Number of participants taking over 85% of medicine
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Derived from this study: PubMed 25167799Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399.
Related trials for Gastric Ulcer Associated With Helicobacter Pylori
Recruiting
Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
Helicobacter Pylori Infection, Peptic Ulcer
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.
Jin Bong Kim, MD study chair
Department of Internal Medicine, Hallym university college of medicine
Yeon Soo Kim, MD, PhD. study director
Department of Internal Medicine, Hallym University College of Medicine
Chang Seok Bang, MD principal investigator
Department of Internal Medicine, Hallym University of College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endonase in people with Gastric Ulcer Associated With Helicobacter Pylori, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 3 inclusion and 7 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eradication rate (time frame: 4 weeks). 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 NCT01645761, 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 22 Jan 2014.