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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01109381
• Other study ID #: GT08-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 20, 2010
• Last updated: March 4, 2014
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2014
• Source: Synergy Pharmaceuticals Pte. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• GT08
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Synergy Pharmaceuticals Pte. Ltd.	Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	Yes