Clinical trial NCT00669955: Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Official title: Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Infections
Keywords: H. Pylori
Quadruple therapy
Eradication rate
Multinational trial
Resistance to antibiotics
Subjects with confirmed Helicobacter Pylori infection
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.

Detailed description: The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.

Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.

Eligibility criteria: Inclusion Criteria:

* Positive H. Pylori status;
* Presence of upper gastro-intestinal symptoms;
* Mental and legal ability to sign informed consent.

Exclusion Criteria:

* Previous surgery of the GI tract;
* Clinically significant impairment of renal or hepatic function;
* Severe unstable cardiovascular, pulmonary or endocrine disease;
* Barrett's oesophagus or high-grade dysplasia;
* Dysphagia or vomiting as major symptoms.

Primary outcomes:
measure: Helicobacter Pylori Eradication Confirmed by Urea Breath Test
timeFrame: Week 6 and week 10 follow-up visits
Secondary outcomes:
measure: Number of Patients Experiencing Treatment Emergent Adverse Events.
timeFrame: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.
measure: H. Pylori Eradication and Presence or Past History of Peptic Ulcers
timeFrame: Week 6 and week 10 follow-up visits
measure: Clarithromycin Resistance
timeFrame: Measured at baseline
measure: Metronidazole Resistance
timeFrame: Measured at baseline
measure: Overall Compliance to Study Medications
timeFrame: At the end of the treatment phase (days 8-14)
measure: Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
timeFrame: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Dr. I. Orpen
Study officials:
affiliation: Axcan Pharma inc
name: Monique Giguère, PhD
role: STUDY_DIRECTOR
References:
citation: Malfertheiner P, Bazzoli F, Delchier JC, Celinski K, Giguere M, Riviere M, Megraud F; Pylera Study Group. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet. 2011 Mar 12;377(9769):905-13. doi: 10.1016/S0140-6736(11)60020-2. Epub 2011 Feb 21.