Trial Outcomes & Findings for Safety and Efficacy Study of a Non-antibiotic Treatment for the Eradication of Helicobacter Pylori (NCT NCT01109381)

Results Overview

Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

33 participants

Primary outcome timeframe

4-6 weeks following treatment

Results posted on

2014-04-02

Participant Flow

Healthy volunteers were recruited, with the first volunteer consenting for screening on 13 May 2010. A total of 205 healthy volunteers were screened for the study, with 164 not being infected with H.pylori and 8 not entering the trial for other inclusion/exclusion reasons.

No group assignment - all participants included were to receive trial treatment. Following consent to take part in the study, participants had a pre-treatment gastroscopy to exclude significant existing upper GI disease. Then all received omeprazole 40mg daily for 1 week prior to receiving the investigational GT08 treatment.

Participant milestones

Participant milestones
Measure	GT08 Initial phase - omeprazole, N-acetylcysteine (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 GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=33 Participants Initial phase - omeprazole, 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 GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Singapore	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-6 weeks following treatment

Population: 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.

Eradication as measured by negative Urea Breath Test 4-6 weeks following completion of treatment

Outcome measures

Outcome measures
Measure	Treatment With GT08 n=31 Participants 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 GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily
Number of Participants With Eradication of H.Pylori Infection	2 participants

PRIMARY outcome

Timeframe: up to 14 days of treatment

Population: 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)

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).

Outcome measures

Outcome measures
Measure	Treatment With GT08 n=20 Participants 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 GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily
Absence of Significant Gastric Abnormality Post-treatment (Initial Phase)	20 participants

SECONDARY outcome

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

Population: All participants entering the study are included in the safety analysis

Adverse event data will be collected in response to neutral questioning.

Outcome measures

Outcome measures
Measure	Treatment With GT08 n=33 Participants 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 GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily
Assessment of Adverse Events (AE)	12 participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=33 participants at risk Initial phase - omeprazole, 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 GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
Gastrointestinal disorders abdominal pain or discomfort	9.1% 3/33 • Number of events 3 • From the time of study entry until 30 days after finishing study treatments or until resolution. Adverse events were recorded by open questioning at study visits, and also recorded if there was any other contact between the participant and the study centre.
Respiratory, thoracic and mediastinal disorders flu like symptoms	21.2% 7/33 • Number of events 7 • From the time of study entry until 30 days after finishing study treatments or until resolution. Adverse events were recorded by open questioning at study visits, and also recorded if there was any other contact between the participant and the study centre.
Gastrointestinal disorders nausea or vomiting	9.1% 3/33 • Number of events 3 • From the time of study entry until 30 days after finishing study treatments or until resolution. Adverse events were recorded by open questioning at study visits, and also recorded if there was any other contact between the participant and the study centre.
Musculoskeletal and connective tissue disorders joint swelling and pain	6.1% 2/33 • Number of events 3 • From the time of study entry until 30 days after finishing study treatments or until resolution. Adverse events were recorded by open questioning at study visits, and also recorded if there was any other contact between the participant and the study centre.

Additional Information

Medical Director

Synergy Pharmaceuticals Pte Ltd

Phone: +64 9 522 4278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60