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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAC 7 days | Active Comparator | Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily |
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| OBMT 10 days | Experimental | OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily. Omeprazole 20 mg is administered twice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole, amoxicillin, clarithromycin | Drug | Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID |
| Measure | Description | Time Frame |
|---|---|---|
| Helicobacter Pylori Eradication Confirmed by Urea Breath Test | H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits. | Week 6 and week 10 follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Treatment Emergent Adverse Events. | A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation. All safety analysis based on the safety population. | at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monique Giguère, PhD | Axcan Pharma inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. I. Orpen | Bath | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21345487 | Derived | 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. |
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If patient was on any contraindicated medications, such as H2 antagonists, sucralfate, or proton pump inhibitors, a washout period of 2 weeks began following informed consent signature, and patient returned to the clinic to perform the endoscopy and the C-13 UBT. Presence of H. pylori needed to be confirmed by C-13 UBT and RUT at least.
First patient in: 11 June 2008 Last patient out: 22 June 2009 Patients were recruited from clinics and hospitals located in seven European Countries: Germany, Poland, Italy, France, Ireland, Spain, United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadruple Therapy (OBMT) 10 Days | Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day) |
| FG001 | Triple Therapy (OAC) 7 Days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole | Drug | Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID. |
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| H. Pylori Eradication and Presence or Past History of Peptic Ulcers | Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows. | Week 6 and week 10 follow-up visits |
| Clarithromycin Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above | Measured at baseline |
| Metronidazole Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml | Measured at baseline |
| Overall Compliance to Study Medications | Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population | At the end of the treatment phase (days 8-14) |
| Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level | Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter) | Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only |
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadruple Therapy (OBMT) 10 Days | Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day) |
| BG001 | Triple Therapy (OAC) 7 Days | Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Helicobacter Pylori Eradication Confirmed by Urea Breath Test | H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits. | No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations. | Posted | Number | Participants | Week 6 and week 10 follow-up visits |
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| Secondary | Number of Patients Experiencing Treatment Emergent Adverse Events. | A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation. All safety analysis based on the safety population. | Safety population, described as all randomized patients having received at least one dose of study medication | Posted | Number | Participants | at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits. |
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| Secondary | H. Pylori Eradication and Presence or Past History of Peptic Ulcers | Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows. | Per protocol population. | Posted | Number | Participants | Week 6 and week 10 follow-up visits |
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| Secondary | Clarithromycin Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above | Per protocol analysis population | Posted | Number | participants | Measured at baseline |
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| Secondary | Metronidazole Resistance | Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml | Per protocol population | Posted | Number | participants | Measured at baseline |
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| Secondary | Overall Compliance to Study Medications | Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population | Safety population. | Posted | Mean | Standard Deviation | participants | At the end of the treatment phase (days 8-14) |
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| Secondary | Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level | Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter) | Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints. | Posted | Number | participants | Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only |
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Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation.
Systematic assessment done for laboratory evaluations and bismuth plasma levels.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quadruple Therapy (OBMT) 10 Days | Omeprazole 20 mg BID (twice a day), and the 3 in 1 capsule, Pylera, containing Bismuth Subcitrate potassium 140 mg, metronidazole 125 mg and tetracycline 125 mg, administered as 3 capsules QID (four times day) | 4 | 216 | 98 | 216 | ||
| EG001 | Triple Therapy (OAC) 7 Days | Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID | 3 | 222 | 105 | 222 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | PT | Non-systematic Assessment |
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| Condition aggravated | General disorders | PT | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | PT | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | PT | Non-systematic Assessment |
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| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PT | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | PT | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | PT | Non-systematic Assessment |
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| Proteus infection | Infections and infestations | PT | Non-systematic Assessment |
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| Pyrexia | General disorders | PT | Non-systematic Assessment |
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| Renal artery stenosis | Renal and urinary disorders | PT | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | PT | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | PT | Non-systematic Assessment |
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| Vascular dementia | Nervous system disorders | PT | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | PT | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | PT | Non-systematic Assessment |
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| e coli urinary tract infection | Infections and infestations | PT | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | PT | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | PT | Non-systematic Assessment |
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| Abdominal pain upper | Vascular disorders | PT | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | PT | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | PT | Non-systematic Assessment |
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| Headache | Gastrointestinal disorders | PT | Non-systematic Assessment |
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Restrictions vary in accordance with the agreement with investigators. Axcan will allow publication after a multi-centre publication or after an agreed period, subject to review by Axcan for confidentiality and intellectual protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monique Giguere, PhD, Programs Director, | Axcan Pharma Inc. | 1-800-565-3255 | 2078 |
| ID | Term |
|---|---|
| D016481 | Helicobacter Infections |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D000658 | Amoxicillin |
| D017291 | Clarithromycin |
| D008795 | Metronidazole |
| D013752 | Tetracycline |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| >=65 years |
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| Male |
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| Spain |
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| France |
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| Germany |
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| Poland |
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| United Kingdom |
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