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
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 3
- Primary Endpoint
- H. pylori status confirmed by Urea Breath Test
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
H. pylori status confirmed by Urea Breath Test
Time Frame: at 6 and 10 weeks following treatment
Secondary Outcomes
- Tolerability(at the end of treatment, one and two months post-treatment)