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

NCT01109381 | Terminated Phase 1 Results

• 1 other identifier: GT08-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

bacterial infections; anti-infective agents; gastrointestinal agents; antibacterial agents; omeprazole; lauric acid; n-acetylcysteine; helicobacter infections; helicobacter pylori; non-antibiotic treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of Adverse Events (AE)

  AE commencing within 30 days of initiation of treatment, followed until resolution

Study Arms (1)

Treatment with GT08

EXPERIMENTAL

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

Interventions

GT08 DRUG

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

Treatment with GT08

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synergy Pharmaceuticals Pte. Ltd.: lead
• Singapore General Hospital: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Bacterial Infections; Helicobacter Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Gram-Negative Bacterial Infections

Limitations and Caveats

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.

Results Point of Contact

• Title: Medical Director
• Organization: Synergy Pharmaceuticals Pte Ltd

damian@pethica.net

+64 9 522 4278

Study Officials

• Ling Khoon Lin, MRCP, DPhil

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 23, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-03

Locations

SG (1)