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

• Status: Unknown status
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Bismuth; Bismuth tripotassium dicitrate; Metronidazole; Omeprazole; Tetracycline

Criteria

Inclusion Criteria:

• An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.

• Subject is male or female.

If the subject is female, she would be eligible to enter if she is of: Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses. Women of childbearing potential should have a negative urine pregnancy test at screening and, if heterosexually active, should agree to use a medically approved method of birth control. Medically approved methods of birth control include:

• Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 14 days of treatment and the 7-day follow-up.

• Approved hormonal contraceptives administered for at least 2 monthly cycles prior to study drug administration, throughout the study period and for 1 monthly cycle following completion of study. An intrauterine device (IUD), inserted by a qualified clinician, at least 1 month prior to study drug administration, throughout the study period and for 1 month following completion of the study.

• Partner has undergone vasectomy and subject is in a monogamous relationship.

• Complete abstinence from intercourse for at least 2 weeks prior to study drug administration and throughout the 14-day of treatment. The investigator is responsible for determining whether the subject has adequate birth control for study participation.

• Subject is at least 18 years of age and not older than 65 years.

• Subject is infected with H. pylori according to results of a urine antibody test and subsequently confirmed by urea breath testing.

• Subject is otherwise in good health, free of liver and kidney disease (as determined by medical history and confirmed by liver and kidney tests at baseline).

• Subject has not received any H. pylori eradication treatment before, not having received antibiotics in the preceding 30 days, or use bismuth compounds more than 3 times per week or other antacids 30 days before taking part in the study.

• Subject is capable of and willing to comply with all study procedures.

Exclusion Criteria:

• Self-prescribed use of antibiotics, or recent (less than 3 months) of medically prescribed antibiotic treatment for H. pylori eradication.

• Subject is taking a macrolide, amoxicillin, metronidazole or any other imidazole during the study.

• Subject is taking another proton pump inhibitor within 7 days of enrollment unless medically prescribed.

• Subject has hypersensitivity or allergy to penicillin, macrolides or initromidazoles.

• Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment.

• Subject has participated in an investigational drug or device study within the 30 days prior to randomization.

• Subject has concomitant disease or condition that could interfere with, or for which treatment could interfere with the conduct of the study, or could in the opinion of the investigator increase the risk of AEs for the subject's participation in the study, such as having neuropathies or being medically diagnosed with epilepsy.

• Subject is unwilling or unable to comply with the study protocol for any other reason.

• Subject is an alcoholic, according to CAGE questionnaire.