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H. Pylori Eradication Using Pyklear in Adults in El Paso, Texas: a Pilot Study

NCT01335334 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-04-14

No results posted yet for this study

Summary

The proposed open-label one arm before-after clinical trial will assess the efficacy of a 14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas. As part of the study we will obtain specimens for culture of H. pylori in a reference laboratory.

Conditions

  • H. Pylori Infection

Interventions

DRUG

bismuth subcitrate potassium, metronidazole,tetracycline hydrochloride and omeprazole

Pylera capsule contains bismuth subcitrate potassium, 140 mg (q.i.d.), metronidazole, 125mg (q.i.d.), tetracycline hydrochloride, 125mg (q.i.d.). Generic omeprazole (20mg, b.i.d) tablets

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01335334 on ClinicalTrials.gov