The Epidemiology and Optimal Treatment of Helicobacter Pylori in Myanmar

NCT04132479 | Completed Phase 4

• 1 other identifier: HC17980
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to:

1. 1.Determine the prevalence of Helicobacter infection in Myanmar (this would be the largest ever series in the country)
2. 2.Determine the clinical and epidemiological associations of Helicobacter infection in Myanmar
3. 3.Determine the utility of stool antigen testing to diagnose the infection and confirm eradication
4. 4.Compare the relative efficacies of concomitant and sequential therapy
5. 5.Determine the relative efficacies of first, second and third line therapies in Myanmar in 2018

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Efficacy of sequential Helicobacter Pylori Eradication Therapy versus concomitant Helicobacter Pylori Eradication Therapy.

  The proportion of participants with a negative stool antigen test 4 weeks after end of treatment in those who received Sequential Helicobacter Pylori Eradication Therapy compared with those who received concomitant Helicobacter Pylori Eradication Therapy.

  4 weeks after completion of initial eradication therapy, at an average of 6 weeks after randomization.

Secondary Outcomes (2)

• The number of participants with adverse drug reactions

  During therapy with the agents and follow up for the 4 weeks after completion of antibiotic therapy; a total of 6 weeks.

• Adherence to therapy

  14 days

Other Outcomes (2)

• Loss to follow up

  Through study completion, an average of 3 months

• Mortality

  Through study completion, an average of 3 months

Study Arms (2)

Sequential therapy

EXPERIMENTAL

Sequential Clarithromycin + Amoxycillin + Tinidazole + rabeprazole by mouth (Both amoxycillin 1000mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days, followed by clarithromycin 500 mg every 12 hours, tinidazole 500mg every 12 hours and rabeprazole 20 mg every 12 hours for 5 days)

Drug: Clarithromycin 500mg; Drug: Amoxicillin 500mg; Drug: Tinidazole 500mg; Drug: Rabeprazole 20mg

Concomitant therapy

ACTIVE COMPARATOR

Concomitant clarithromycin 500mg every 12 hours + amoxycillin 1000mg every 12 hours + tinidazole 500mg every 12 hours + rabeprazole 20mg every 12 hours (all drugs by mouth for 14 days).

Drug: Clarithromycin 500mg; Drug: Amoxicillin 500mg; Drug: Tinidazole 500mg; Drug: Rabeprazole 20mg

Interventions

Clarithromycin 500mg DRUG

1000mg taken orally every 12 hours for 5 days

Also known as: Getz Pharma, Karachi, Pakistan

Sequential therapy

Amoxicillin 500mg DRUG

1000mg taken orally every 12 hours for 5 days

Also known as: Denk Pharma, Munich, Germany

Sequential therapy

Tinidazole 500mg DRUG

500mg taken orally every 12 hours for 5 days

Also known as: Global Pharma, Chennai, India

Sequential therapy

Rabeprazole 20mg DRUG

20mg taken orally every 12 hours for 5 days

Also known as: Zifam Pinnacle, Mumbai, India

Sequential therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Satisfies one of the criteria for H. pylori testing in the 2017 American College of Gastroenterology guidelines
• Informed consent

You may not qualify if:

• No informed consent

Sponsors & Collaborators

• Kirby Institute: lead
• University of Medicine 2, Yangon, Myanmar: collaborator

Study Sites (1)

Insein General Hospital

Yangon, 11011, Burma

Location

MeSH Terms

Interventions

Clarithromycin; Amoxicillin; Tinidazole; Rabeprazole

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles

Study Officials

• Mar Mar Kyi, MD

  University of Medicine 2, Yangon, Myanmar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised control trial

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: April 9, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)