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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669955
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : August 5, 2010
Last Update Posted : March 16, 2017
Information provided by (Responsible Party):
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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 UBT. Presence of H. pylori needed to be confirmed by C-13 UBT and RUT at least.

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 Omeprazole 20 mg BID, Amoxicillin 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 Judgement                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

  Outcome Measures

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

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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  More Information