Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori

This study has been terminated.
(Poor efficacy (2 of 31 completing participants with H.pylori eradication))
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Synergy Pharmaceuticals Pte. Ltd.
ClinicalTrials.gov Identifier:
NCT01109381
First received: April 20, 2010
Last updated: March 4, 2014
Last verified: March 2014
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Helicobacter Pylori Infection
Intervention: Drug: GT08

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy volunteers were recruited, with the first volunteer consenting for screening on 13 May 2010. A total of 205 healthy volunteers were screened for the study, with 164 not being infected with H.pylori and 8 not entering the trial for other inclusion/exclusion reasons.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No group assignment - all participants included were to receive trial treatment. Following consent to take part in the study, participants had a pre-treatment gastroscopy to exclude significant existing upper GI disease. Then all received omeprazole 40mg daily for 1 week prior to receiving the investigational GT08 treatment.

Reporting Groups
  Description
GT08

Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid

GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily


Participant Flow:   Overall Study
    GT08  
STARTED     33  
COMPLETED     31  
NOT COMPLETED     2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid

GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily


Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     0  
Gender  
[units: participants]
 
Female     13  
Male     20  
Region of Enrollment  
[units: participants]
 
Singapore     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Eradication of H.Pylori Infection   [ Time Frame: 4-6 weeks following treatment ]

2.  Primary:   Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)   [ Time Frame: up to 14 days of treatment ]

3.  Secondary:   Assessment of Adverse Events (AE)   [ Time Frame: AE commencing within 30 days of initiation of treatment, followed until resolution ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The trial has no control group. All participants had current H.pylori infection at study entry. Only two participants had this infection eradicated, making an efficacy control group unnecessary.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Synergy Pharmaceuticals Pte Ltd
phone: +64 9 522 4278
e-mail: damian@pethica.net


No publications provided


Responsible Party: Synergy Pharmaceuticals Pte. Ltd.
ClinicalTrials.gov Identifier: NCT01109381     History of Changes
Other Study ID Numbers: GT08-01
Study First Received: April 20, 2010
Results First Received: May 23, 2013
Last Updated: March 4, 2014
Health Authority: Singapore: Health Sciences Authority