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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Pylera

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No