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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
Results First Received: June 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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
  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 Omeprazole 20 mg BID, Amoxicillin 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 
Overall Participants Analyzed 
[Units: Participants]
 218   222   440 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      184  84.4%      194  87.4%      378  85.9% 
>=65 years      34  15.6%      28  12.6%      62  14.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.53  (14.64)   47.95  (14.52)   48.24  (14.58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      105  48.2%      100  45.0%      205  46.6% 
Male      113  51.8%      122  55.0%      235  53.4% 
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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