Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
This study is currently recruiting participants.
Verified July 2012 by Chuncheon Sacred Heart Hospital
Sponsor:
Chuncheon Sacred Heart Hospital
Information provided by (Responsible Party):
Yeonsoo Kim, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01645761
First received: July 16, 2012
Last updated: July 18, 2012
Last verified: July 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 16, 2012 | ||||||||
| Last Updated Date | July 18, 2012 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Eradication rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] 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 |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01645761 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori | ||||||||
| Official Title ICMJE | Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori | ||||||||
| Brief 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. 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. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Helicobacter Pylori Associated Peptic Ulcer | ||||||||
| Intervention ICMJE | Drug: Endonase
PPI- based triple therapy with endonase |
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 216 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Male or Female with 18 years or more of age without history of H. pylori eradication AND
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01645761 | ||||||||
| Other Study ID Numbers ICMJE | CSHH Endonase 1, CLDD 1 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yeonsoo Kim, Chuncheon Sacred Heart Hospital | ||||||||
| Study Sponsor ICMJE | Chuncheon Sacred Heart Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Chuncheon Sacred Heart Hospital | ||||||||
| Verification Date | July 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||