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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

April 20, 2010
March 4, 2014
May 2010
December 2011   (final data collection date for primary outcome measure)
  • Number of Participants With Eradication of H.Pylori Infection [ Time Frame: 4-6 weeks following treatment ] [ Designated as safety issue: No ]
    Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment
  • Absence of Significant Gastric Abnormality Post-treatment (Initial Phase) [ Time Frame: up to 14 days of treatment ] [ Designated as safety issue: Yes ]
    Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).
  • Eradication of H.pylori infection as measured by Urea Breath Test 4-6 weeks following completion of treatment [ Time Frame: 4-6 weeks following treatment ] [ Designated as safety issue: No ]
  • Absence of significant gastric abnormality post-treatment (Initial Phase) [ Time Frame: Pre- and post-treatment gastroscopy ] [ Designated as safety issue: Yes ]
    Gastroscopy pre- and post-treatment will be performed in the Initial Phase (20 participants), with the goal of excluding significant gastric abnormality at baseline and after treatment (e.g. gastric ulceration arising following the treatment).
Complete list of historical versions of study NCT01109381 on ClinicalTrials.gov Archive Site
Assessment of Adverse Events (AE) [ Time Frame: AE commencing within 30 days of initiation of treatment, followed until resolution ] [ Designated as safety issue: Yes ]
Adverse event data will be collected in response to neutral questioning.
Assessment of adverse events [ Time Frame: AE commencing within 30 days of initiation of treatment, followed until resolution ] [ Designated as safety issue: Yes ]
Adverse event data will be collected in response to neutral questioning.
Not Provided
Not Provided
 
Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori
A Single-centre, Open-label, Non-controlled, Exploratory Safety and Efficacy Clinical Trial of GT08 in Volunteers and Patients Who Are Infected With Helicobacter Pylori

At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in triple therapy. This study explores a non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with omeprazole following administration of a mucolytic agent to kill H.pylori topically in the stomach.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori Infection
Drug: GT08
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
Experimental: Treatment with GT08
Initial phase - omeprazole, N-acetyl cysteine (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
Intervention: Drug: GT08
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed Consent prior to any study procedure
  • Age at least 21 years and up to 70 years
  • If female of childbearing potential who is sexually active, agrees to use acceptable methods of birth control throughout the study. Acceptable methods of birth control are: hormonal contraceptives (birth control pills), intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy.

Additional Inclusion Criteria for Initial Phase only

  • Healthy volunteers - can have gastrointestinal or other symptoms if these do not require medical treatment and are considered by the investigator to be clinically minor and irrelevant to the conduct of the study.
  • Positive laboratory serology for H.pylori
  • Positive Urea Breath Test for H.pylori
  • Willing to undergo two gastroscopy procedures

Additional Inclusion Criteria for Secondary Phase only

  • Either healthy volunteers or patients attending gastroenterology outpatient clinic - can have gastrointestinal or other symptoms if these are considered by the investigator to be clinically minor or irrelevant to the conduct of the study.
  • Positive diagnosis of current H.pylori infection, as diagnosed by positive Urea Breath Test and at least one of the following: 1) Positive laboratory serology for H.pylori, 2) known positive Campylobacter-like organism (CLO) test or H.pylori culture from a gastroscopy performed in the 1 year prior to Screening.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Clinically significant gastric disease, in the opinion of the investigator.
  • Significant disease or disorder on general medical examination, in the opinion of the investigator (general, respiratory, cardiovascular, renal, hepatic, neurological, bleeding tendency etc).
  • Regular or intermittent use of antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or antiplatelet medications is expected during the trial period.
  • Cessation of proton pump inhibitor or H2-blocker therapy for 2 weeks prior to Urea Breath Test is likely to not be in the best interests of the participant.
  • Laboratory values on blood testing that are outside of the laboratory normal range and considered clinically relevant by the investigator: the following will be screened Haemoglobin (Hb), bilirubin, aspartate transaminase (AST), alanine transaminase (ALT), serum albumin, Alkaline Phosphatase, Urea, sodium (Na), potassium (K), creatinine (CRE).
  • Any contraindication to treatment with omeprazole, N-acetyl cysteine (NAC), or sodium bicarbonate.
  • Any evidence of organic or psychiatric disorders likely to result in poor compliance in the opinion of the investigator.
  • Previous participation in this trial at any time, or participation in any other clinical trial within the previous 3 months.
Both
21 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01109381
GT08-01
No
Synergy Pharmaceuticals Pte. Ltd.
Synergy Pharmaceuticals Pte. Ltd.
Singapore General Hospital
Principal Investigator: Ling Khoon Lin, MRCP, DPhil Singapore General Hospital
Synergy Pharmaceuticals Pte. Ltd.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP