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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:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00669955
First received: April 29, 2008
Last updated: August 3, 2010
Last verified: August 2010

April 29, 2008
August 3, 2010
June 2008
July 2009   (final data collection date for primary outcome measure)
Helicobacter Pylori Eradication Confirmed by Urea Breath Test [ Time Frame: Week 6 and week 10 follow-up visits ] [ Designated as safety issue: No ]
H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.
Helicobacter Pylori Status confirmed by Urea Breath Test [ Time Frame: One month and two months post-treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669955 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)
Safety [ Time Frame: at the end of treatment, one and two months post-treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Infections
  • 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
  • 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
  • Active Comparator: OAC 7 days
    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
    Intervention: Drug: Omeprazole, amoxicillin, clarithromycin
  • 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 a day. Omeprazole 20 mg is administered twice a day,
    Intervention: Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
Malfertheiner P, Bazzoli F, Delchier JC, Celiñski K, Giguère M, Rivière M, Mégraud 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. Erratum in: Lancet. 2011 Nov 19;378(9805):1778. Dosage error in article text.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
440
August 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00669955
PYLHp07-01
No
Dr. Monique Giguere, Axcan Pharma inc.
Axcan Pharma
Not Provided
Study Director: Monique Giguère, PhD Axcan Pharma inc
Axcan Pharma
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP