Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days

Phase 3

Completed

• Conditions: 10017966; 10004018; Gastric complaints; Helicobacter infection

• Registration Number: NL-OMON32065
• Lead Sponsor: Axcan Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

-Male or non-pregnant, non-nursing female, 18 years of age and older
-Positive for Helicobacter pylori by both C-13 UBT and at least two of three positive results among rapid urease test, histologic examination and/or culture
-Presence of upper gastrointestinal symptoms

Exclusion Criteria

-Previous surgery of the upper gastrointestinal tract (except appendectomy, polypectomy, or cholecystectomy)
-Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance
-Barrett*s esophagus or high-grade dysplasia
-Dysphagia or vomiting as major symptoms
-Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylori.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Eradication rate, defined as two negative C-13 urea breath tests performed at 6<br /><br>and 10 weeks following initiation of therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.<br /><br>To compare eradication outcomes in patients with presence/past history of<br /><br>peptic ulcers at baseline vs those without.<br /><br>2.<br /><br>To evaluate the effect of resistance of Helicobacter pylori to metronidazole<br /><br>and clarithromycin on the efficacy of these treatments.<br /><br>3.<br /><br>To evaluate the rate of secondary resistance induced by these treatments.<br /><br>4.<br /><br>To assess the safety and tolerability of these therapeutic regimens with<br /><br>respect to subject-reported and investigator-observed adverse events, clinical<br /><br>laboratory abnormalities and plasma bismuth (Bi) concentrations.<br /><br>5.<br /><br>To evaluate compliance to treatment.</p><br>