NCT02422706

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Status unknown Phase 3 Last updated 23 April 2017

What this trial tests

Phase 3 trial testing Nitazoxanide in Helicobacter-associated Gastritis in 120 participants. Status unknown.

Timeline

1 January 2015

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Sherief Abd-Elsalam
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	1 January 2015
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across Egypt

Drugs / interventions tested

• Nitazoxanide (NITAZOXANIDE) — full drug profile →
• Metronidazole(MTZ)
• Omeprazole (omeprazole) — full drug profile →
• Clarithromycin (clarithromycin) — full drug profile →
• Levofloxacin (Levofloxacin) — full drug profile →
• Doxicycline — full drug profile →

Conditions studied

• Helicobacter-associated Gastritis — all drugs for Helicobacter-associated Gastritis →

Sponsor

Sherief Abd-Elsalam — full company profile →

Who can join

Eligibility, any sex, with Helicobacter-associated Gastritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of patients with proven eradication of helicobacter
  Time frame: 6 weeks
  Number of patients with proven eradication of helicobacter after 6 weeks

Sponsor's own description

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .

However, a recent study based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in \~30% of patients on an intention-to-treat (ITT) basis, and will fail in \~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue warranting the investigation of other agents. Helicobacter pylori infection has become increasingly resistant to traditional first-line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates. So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection.
   Shehata MA, Talaat R, Soliman S, Elmesseri H, et al · · 2017 · cited 28× · PMID 28524341 · DOI 10.1111/hel.12395
2. UEG Week 2017 Poster Presentations
   · 2017 · cited 1×