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.

Study Overview

• Status: Terminated
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: GT08

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Eradication of H.Pylori Infection	Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment	4-6 weeks following treatment
Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)	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).	up to 14 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Adverse Events (AE)	Adverse event data will be collected in response to neutral questioning.	AE commencing within 30 days of initiation of treatment, followed until resolution

Collaborators and Investigators

• Sponsor: Synergy Pharmaceuticals Pte. Ltd.
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Ling Khoon Lin, MRCP, DPhil, Singapore General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (ESTIMATE): April 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: bacterial infections; omeprazole; n-acetylcysteine; lauric acid; helicobacter pylori; anti-infective agents; antibacterial agents; gastrointestinal agents; helicobacter infections; non-antibiotic treatment
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: GT08-01