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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
History of Changes
Results First Received: June 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Helicobacter Infections
Interventions: Drug: Omeprazole, amoxicillin, clarithromycin
Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 urea breath test. Presence of H pylori needed to be confirmed by C-13 UBT and RUT at least.

Reporting Groups
  Description
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)
Triple Therapy (OAC) 7 Days Ompeprazole 20 mg BID, Amoxicilin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID

Participant Flow:   Overall Study
    Quadruple Therapy (OBMT) 10 Days     Triple Therapy (OAC) 7 Days  
STARTED     218 [1]   222  
COMPLETED     204     195  
NOT COMPLETED     14     27  
Adverse Event                 3                 5  
Death                 0                 1  
Withdrawal by Subject                 2                 3  
Lost to Follow-up                 5                 7  
Protocol Violation                 2                 7  
Investigator Sponsor Jugement                 0                 1  
not compliant with study drug/visit                 2                 3  
[1] 216 patients received study drug. 2 patients were dispensed study drug but did not take it



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Helicobacter Pylori Eradication Confirmed by Urea Breath Test   [ Time Frame: Week 6 and week 10 follow-up visits ]
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2.  Secondary:   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. ]
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3.  Secondary:   H. Pylori Eradication and Presence or Past History of Peptic Ulcers   [ Time Frame: Week 6 and week 10 follow-up visits ]
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4.  Secondary:   Clarithromycin Resistance   [ Time Frame: Measured at baseline ]
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5.  Secondary:   Metronidazole Resistance   [ Time Frame: Measured at baseline ]
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6.  Secondary:   Overall Compliance to Study Medications   [ Time Frame: At the end of the treatment phase (days 8-14) ]
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7.  Secondary:   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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Monique Giguere, PhD, Programs Director,
Organization: Axcan Pharma Inc.
phone: 1-800-565-3255 ext 2078


No publications provided by Axcan Pharma

Publications automatically indexed to this study:


Responsible Party: Dr. Monique Giguere, Axcan Pharma inc.
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: August 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service
Spain: Ethics Committee
Spain: Ministry of Health
Poland: Ministry of Health
Ireland: Irish Medicines Board
Italy: National Bioethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medicines Evaluation Board (MEB)