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Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00669955
First received: April 29, 2008
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Helicobacter Infections
Drug: Omeprazole, amoxicillin, clarithromycin
Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Helicobacter Pylori Eradication Confirmed by Urea Breath Test [ Time Frame: Week 6 and week 10 follow-up visits ]
    H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.


Secondary Outcome Measures:
  • Number of Patients Experiencing Treatment Emergent Adverse Events. [ Time Frame: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits. ]

    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.


  • H. Pylori Eradication and Presence or Past History of Peptic Ulcers [ Time Frame: Week 6 and week 10 follow-up visits ]
    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.

  • Clarithromycin Resistance [ Time Frame: Measured at baseline ]
    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

  • Metronidazole Resistance [ Time Frame: Measured at baseline ]
    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

  • Overall Compliance to Study Medications [ Time Frame: At the end of the treatment phase (days 8-14) ]
    Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population

  • Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level [ Time Frame: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only ]
    Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)


Enrollment: 440
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OAC 7 days
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
Drug: Omeprazole, amoxicillin, clarithromycin
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
Experimental: OBMT 10 days
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.
Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
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.
Other Name: Pylera

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669955

Locations
United Kingdom
Dr. I. Orpen
Bath, United Kingdom
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Monique Giguère, PhD Axcan Pharma inc
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00669955     History of Changes
Other Study ID Numbers: PYLHp07-01
Study First Received: April 29, 2008
Results First Received: June 21, 2010
Last Updated: February 8, 2017

Keywords provided by Forest Laboratories:
H. Pylori
Quadruple therapy
Eradication rate
Multinational trial
Resistance to antibiotics
Subjects with confirmed Helicobacter Pylori infection

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bismuth
Bismuth tripotassium dicitrate
Omeprazole
Tetracycline
Metronidazole
Clarithromycin
Amoxicillin
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anti-Infective Agents
Anti-Ulcer Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Proton Pump Inhibitors
Antiprotozoal Agents
Antiparasitic Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 24, 2017