Helicobacter Pylori InfectionPhase 1/2NCT01109381

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

A Phase 1/2 study testing GT08 in people with Helicobacter Pylori Infection, run by Synergy Pharmaceuticals Pte. Ltd. at 1 site in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Helicobacter Pylori Infection
What is being tested?: GT08
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteSingapore
Study dates: May 2010to Dec 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

Singapore General Hospital
Singapore

Other trials in Singapore

About this study

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

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
Being tested: GT08
Keywords: bacterial infections, anti-infective agents, gastrointestinal agents, antibacterial agents, omeprazole, lauric acid, n-acetylcysteine, helicobacter infections, helicobacter pylori, non-antibiotic treatment
Medical subject headings: Bacterial Infections, Helicobacter Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GT08Drug
GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

Study groups in NCT01109381
Study group	Role	What they receive
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 Receives: Drug: GT08

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Eradication of H.Pylori Infection
Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment
Measured: 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).
Measured: up to 14 days of treatment

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2011

First posted23 Apr 2010 (estimated)
Study startMay 2010
Primary completionDec 2011
Study completionDec 2011

Why it stopped: Poor efficacy (2 of 31 completing participants with H.pylori eradication)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01109381
Sponsor's protocol ID: GT08-01
Status last verified: Mar 2014
First submitted: 20 Apr 2010
Last updated: 2 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer

All Helicobacter Pylori Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01109381
Acronym / sponsor ID: GT08-01
Conditions: Helicobacter Pylori Infection
Keywords: bacterial infections, anti-infective agents, gastrointestinal agents, antibacterial agents, omeprazole, lauric acid, n-acetylcysteine, helicobacter infections
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor efficacy (2 of 31 completing participants with H.pylori eradication)
Enrolment: 33 participants (actual)
Lead sponsor: Synergy Pharmaceuticals Pte. Ltd.Industry (pharma, biotech, devices)
Collaborators: Singapore General Hospital
Study start: May 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 23 Apr 2010 (estimated)
Results: Posted 2 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment with GT08	Experimental	Drug: GT08Initial 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

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GT08GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily	Drug	Treatment with GT08

Primary outcome

Number of Participants With Eradication of H.Pylori Infection
Time frame: 4-6 weeks following treatment
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
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).

1 secondary outcome

Assessment of Adverse Events (AE)
Time frame: AE commencing within 30 days of initiation of treatment, followed until resolution

Results and safety

Results posted to the registry on 2 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GT08	33	31

Primary outcome: Number of Participants With Eradication of H.Pylori Infection

Time frame: 4-6 weeks following treatment. Number. Unit: participants

Measure	Treatment With GT08 n = 31
Value	2

Population analysed: Two participants did not complete the study, one discontinuing after experiencing adverse events while receiving only the initial study omeprazole, and the other participant left Singapore before they had their final urea breath test. All other study participants were analysed for efficacy.

Primary outcome: Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)

Time frame: up to 14 days of treatment. Number. Unit: participants

Measure	Treatment n = 20
Value	20

Population analysed: All 21 Initial Phase participants had a pretreatment gastroscopy, and 20 had post-treatment gastroscopy (one participant prematurely discontinued the study prior to receiving GT08, and the participant later lost to follow up had a post-treatment gastroscopy before being lost to follow up)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the time of study entry until 30 days after finishing study treatments or until resolution.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 33 (0%)	12 of 33 (36.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Helicobacter Pylori Infection

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ling Khoon Lin, MRCP, DPhil principal investigator

Singapore General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GT08 in people with Helicobacter Pylori Infection, run by Synergy Pharmaceuticals Pte. Ltd. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Eradication of H.Pylori Infection (time frame: 4-6 weeks following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.