Helicobacter pylori infection MedDRA version: 9.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection MedDRA version: 9.1 Level: SOC Classification code 10021881 Term: Infections and infestations
Conditions
Interventions
Product Name: Pylera
Pharmaceutical Form: Capsule*
INN or Proposed INN: Bismuth subcitrate potassium
CAS Number: 880149-29-1
Other descriptive name: biskalcitrate
Concentration unit: mg milligram(s)
Sponsors
Axcan Pharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or non-pregnant, non-nursing female, 18 years of age and older • Women of childbearing potential must use a medically acceptable birth control method for the duration of the study and for 30 days thereafter. Women who are not of childbearing potential will be defined as post-menopausal (no presence of menses for at least 12 months) or surgically sterilized (tubal ligation for at least 6 months, ovariectomy or hysterectomy) • Positive for Helicobacter pylori by both C-13 UBT and at least two of three positive results among rapid urease test, histologic examination and/or culture • Presence of upper gastrointestinal symptoms • Mental and legal ability to give written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous surgery of the upper gastrointestinal tract (except appendectomy, polypectomy, or cholecystectomy) • Presence or history of clinically significant impairment of renal function, hepatic function, or liver disease • Presence or history of severe or unstable cardiovascular, pulmonary or endocrine disease • Presence or history of Zollinger Ellison Syndrome • Any current or recent (within 1 month of screening) hematemesis, melena, or documented gastrointestinal bleeding or iron-deficiency anaemia of clinical significance • Malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) during the previous 5 years • Barrett’s esophagus or high-grade dysplasia • Dysphagia or vomiting as major symptoms • Drug, alcohol or medication abuse within the past year • Continuous use of anti-ulcer drugs, including H2 receptor antagonists, sucralfate and prostaglandins during the 2 weeks preceding the C 13 UBT at screening • Continuous use of proton pump inhibitor in the 2 weeks preceding the C 13 UBT at screening • Chronic use of NSAIDs, except for acetyl-salicylic acid 100 mg or less daily • Requirement for anticoagulants (except for acetyl-salicylic acid 100 mg or less daily) and glucocorticoids (because of association with ulcer disease) • Use of antibiotics in the month before randomization • Regular use (> 3 times per week) of bismuth compounds in the month before randomization. • Presence of a contraindication to the use of metronidazole: e.g. active neurological disorder, history of blood dyscrasia, uncorrected hypothyroidism, uncorrected hypoadrenalism, or alcoholism, tetracycline (known sensitivity to tetracyclines), clarithromycin (known hypersensitivity to macrolides, use of cisapride, pimozide, terfenadine, astemizole and ergotamine/dihydroergotamine), amoxicillin (known sensitivity to penicilins), or omeprazole (known sensitivity to omeprazole). • Use of any experimental drug within the 30 days prior to randomization. • Previous attempt by a recognized antibiotic treatment to eradicate an adequately documented infection by Helicobacter pylori. • Known hypersensitivity to or previous adverse experience(s) with citric acid or any of the study drugs. • Patient known to be positive for HIV, hepatitis, or other diseases transmissible by blood or biopsy samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the rate of Helicobacter pylori eradication following quadruple therapy by a single triple capsule of bismuth subcitrate potassium, metronidazole, and tetracycline, given with omeprazole (OBMT) vs omeprazole, amoxicillin and clarithromycin (OAC) in Helicobacter pylori positive patients. ;Secondary Objective: 1. To compare eradication outcomes in patients with presence/past history of peptic ulcers at baseline vs those without. 2. To evaluate the effect of resistance of Helicobacter pylori to metronidazole and clarithromycin on the efficacy of these treatments. 3. To evaluate the rate of secondary resistance induced by these treatments. 4. To assess the safety and tolerability of these therapeutic regimens with respect to patient-reported and investigator-observed adverse events, clinical laboratory abnormalities and plasma Bi concentrations. 5. To evaluate compliance to treatment. ;Primary end point(s): A one-sided 97.5% confidence interval on the difference of proportions (OBMT eradication rate – OAC eradication rate) will be derived using asymptotic normal approximation procedure and we will conclude to non-inferiority of OBMT if the lower bound of the confidence interval is greater than or equal to -10%. If, and only if, we conclude to non-inferiority of OBMT over OAC using the Per Protocol population, the same confidence interval will be derived using the ITT population. If the lower bound of this confidence interval is greater than 0, we will conclude to superiority of OBMT over OAC. The type I error rate is controlled by first testing non-inferiority using the Per Protocol population and, only if non inferiority is demonstrated, then testing for superiority using the ITT population. This stepwise procedure does not require any type I error rate adjustment28,29. Non-inferiority will be evaluated using both the Per Protocol population (primary) and the ITT population (supportive). Super | — |
Countries
France, Germany, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed