NCT02395458

Brief Summary

Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

March 12, 2015

Last Update Submit

March 17, 2015

Conditions

Helicobacter Infections

Keywords

Sequential therapyTriple therapyEradication

Outcome Measures

Primary Outcomes (1)

  • Eradication

    Helicobacter pylori in gastric biopsy

    6 to 8 week after treatment

Secondary Outcomes (1)

  • Side effects

    two weeks after beginning of treatment

Study Arms (2)

Sequential therapy

EXPERIMENTAL

Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days

Drug: Sequential therapy

Triple therapy

ACTIVE COMPARATOR

Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days

Drug: Triple therapy

Interventions

Sequential therapyDRUG

Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days

Also known as: Omeprazole-Amoxicillin-Clarithromycin-Metronidazole
Sequential therapy
Triple therapyDRUG

Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days

Also known as: Omeprazole-Clarithromycin-Metronidazole
Triple therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Helicobacter pylori infection in biopsy
  • Eradication required

You may not qualify if:

  • Antibiotic received two weeks prior
  • Previous treatment for H pylori infection
  • Allergy to any of the treatment drugs
  • Smoking \> 5 cigarettes daily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Clinical Research Centre

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 23, 2015

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 23, 2015

Record last verified: 2015-03