14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

NCT04769583 | Completed Phase 4

• 1 other identifier: TN2018-INT-INS-14
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Conditions

Gastritis H Pylori

Keywords

Breath Tests; Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• HP eradiction rate

  assessment by breath test

  6 weeks after completion of study treatment

Secondary Outcomes (1)

• percentage of adverse reactions

  3 months

Study Arms (2)

concomitant quadruple therapy (QC)

ACTIVE COMPARATOR

PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days

Drug: metronidazole based quadriple therapy

triple therapy (TT)

PLACEBO COMPARATOR

PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days.

Drug: placebo based quadriple therapy

Interventions

metronidazole based quadriple therapy DRUG

patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)

Also known as: concomitant quadruple therapy (QC)

concomitant quadruple therapy (QC)

placebo based quadriple therapy DRUG

patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.

Also known as: Triple therapy (TT)

triple therapy (TT)

Eligibility Criteria

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

You may qualify if:

• patients aged between 18 and 65, with documented Hp infection.

You may not qualify if:

• With Cirrhosis.
• With Renal failure (serum creatinine\> 120 µmol / L).
• Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
• Having severe psychiatric disorders.
• Having had gastric surgery in their history.
• Having already received an HP eradication treatment.
• Having received an antibiotic within the last two weeks.
• Who are allergic to one of the antibiotics used in the anti-Hp cure.
• Who are drug addicted.

Sponsors & Collaborators

• mohamed bouchoucha: lead

Study Sites (1)

Fattouma Bourguiba Hospital

Monastir, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: a placebo which has the same visual characteristics as metronidazole in the boxes of the triple therapy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Data management

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 24, 2021
• Study Start: February 10, 2019
• Primary Completion: February 17, 2020
• Study Completion: March 5, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

TU (1)