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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00712413

Enrollment

Registered

2008-07-10

Start date

2008-08-31

Completion date

2008-12-31

Last updated

2017-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection, Quadruple therapy, Safety, Efficacy, Tolerability, BID dosing

Brief 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.

Detailed 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

Interventions

DRUGOBMT

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
H. pylori status confirmed by Urea Breath Test	at 6 and 10 weeks following treatment

Secondary

Measure	Time frame
Tolerability	at the end of treatment, one and two months post-treatment

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026