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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.
Information provided by:
Axcan Pharma Identifier:
First received: April 29, 2008
Last updated: August 3, 2010
Last verified: August 2010
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

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
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
Total Total of all reporting groups

Baseline Measures
    Quadruple Therapy (OBMT) 10 Days     Triple Therapy (OAC) 7 Days     Total  
Number of Participants  
[units: participants]
  218     222     440  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     184     194     378  
>=65 years     34     28     62  
[units: years]
Mean (Standard Deviation)
  48.53  (14.64)     47.95  (14.52)     48.24  (14.58)  
[units: participants]
Female     105     100     205  
Male     113     122     235  
Region of Enrollment  
[units: participants]
Italy     10     10     20  
Spain     7     6     13  
France     15     17     32  
Germany     92     91     183  
Poland     91     93     184  
United Kingdom     3     5     8  

  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 ]

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. ]

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

4.  Secondary:   Clarithromycin Resistance   [ Time Frame: Measured at baseline ]

5.  Secondary:   Metronidazole Resistance   [ Time Frame: Measured at baseline ]

6.  Secondary:   Overall Compliance to Study Medications   [ Time Frame: At the end of the treatment phase (days 8-14) ]

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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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