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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
  Purpose

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.


Condition Intervention Phase
Helicobacter Pylori Infection
Drug: GT08
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Pte. Ltd.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: GT08
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109381

Locations
Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Synergy Pharmaceuticals Pte. Ltd.
Singapore General Hospital
Investigators
Principal Investigator: Ling Khoon Lin, MRCP, DPhil Singapore General Hospital
  More Information

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

Keywords provided by Synergy Pharmaceuticals Pte. Ltd.:
bacterial infections
anti-infective agents
gastrointestinal agents
antibacterial agents
omeprazole
lauric acid
n-acetylcysteine
helicobacter infections
helicobacter pylori
non-antibiotic treatment

Additional relevant MeSH terms:
Communicable Diseases
Helicobacter Infections
Infection
Bacterial Infections
Gram-Negative Bacterial Infections
Omeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014