Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

Pilot Study Assessing the Safety, Tolerability, Compliance and Efficacy of Twice Daily Dosed Pylera Plus Omeprazole as a First Line Treatment of Helicobacter Pylori Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00712413
• Other study ID #: PYLHp08-01
• Status: Withdrawn
• Phase: Phase 3
• First received: July 8, 2008
• Last updated: February 8, 2017
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

Description:

This study will include three phases: screening, treatment and follow-up.

Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc).

Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14.

Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive H. pylori status through UBT testing

Exclusion Criteria:

• Documented allergy to any of the drugs contained in the treatment regimen

• Severe renal insufficiency, renal failure or azotemia

• Previous surgery of the upper gastrointestinal tract

• Hepatic failure

• Pre-existing peripheral neuropathies

• Use of any experimental drug within 30 days prior to randomization

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• OBMT
Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of Pylera, in addition to 1 omeprazole twice daily

Locations

Country	Name	City	State
Canada	McMaster University Medical Center, Division of Gastroenterology	Hamilton	Ontario
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Aurora Health Care	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori status confirmed by Urea Breath Test		at 6 and 10 weeks following treatment
Secondary	Tolerability		at the end of treatment, one and two months post-treatment