Trial record 21 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

A Two Week Nitazoxanidebased Quadruple Regimen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02621359
Recruitment Status : Recruiting
First Posted : December 3, 2015
Last Update Posted : January 3, 2018
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:

Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Nitazoxanide Drug: Levofloxacin Drug: Doxycyclin Drug: Omeprazole Phase 3

Detailed Description:

Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
Study Start Date : January 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Quadruple therapy
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Drug: Nitazoxanide
Nitazoxanide 500 mg twice daily
Other Name: Alenia, nitclean, parazoxanide
Drug: Levofloxacin
Levofloxacin 500 mg once daily
Other Name: Tavanic, levoxin, venaxan.
Drug: Doxycyclin
Doxycyclin 100 mg twice daily
Other Name: Vibramycin, Doxymycin
Drug: Omeprazole
Omeprazole 40 mg twice daily
Other Name: Omepak, Pepzole, Gasec, Risek.

Primary Outcome Measures :
  1. Number of patients with eradicated helicobacter [ Time Frame: 1 year ]
    The total number of patients with eradicated helicobacter

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with helicobacter infection.
  • in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion Criteria:

  • Patients under 18 or over 65 years of age.
  • Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
  • pregnancy/lactation
  • having contraindication or allergy to any of the study drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02621359

Contact: Sherief Abd-Elsalam, lecturer 00201095159522

Tropical medicine dept.-Tanta university hospital Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam, lecturer    00201095159522   
Sponsors and Collaborators
Tanta University
Principal Investigator: Sherief Abd-Elsalam, lecturer Tropical medicine-Tanta university hospital

Responsible Party: Sherief Abd-Elsalam, Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator, Tanta University Identifier: NCT02621359     History of Changes
Other Study ID Numbers: Quadruple therapy
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors