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Trial record 20 of 201 for:    TETRACYCLINE

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.
 
ClinicalTrials.gov Identifier: NCT00669955
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : August 5, 2010
Last Update Posted : March 16, 2017
Sponsor:
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
Enrollment 440
Recruitment Details 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 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.
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description 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) Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Period Title: Overall Study
Started 218 [1] 222
Completed 204 195
Not Completed 14 27
Reason Not Completed
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
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days Total
Hide Arm/Group Description 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) Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID Total of all reporting groups
Overall Number of Baseline Participants 218 222 440
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 222 participants 440 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 222 participants 440 participants
48.53  (14.64) 47.95  (14.52) 48.24  (14.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 222 participants 440 participants
Female
105
  48.2%
100
  45.0%
205
  46.6%
Male
113
  51.8%
122
  55.0%
235
  53.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 218 participants 222 participants 440 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
1.Primary Outcome
Title Helicobacter Pylori Eradication Confirmed by Urea Breath Test
Hide Description H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.
Time Frame Week 6 and week 10 follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
No imputation method used, as this is the per protocol population, which excludes patients with missing values, or with protocol violations.
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 178 161
Measure Type: Number
Unit of Measure: Participants
166 112
2.Secondary Outcome
Title Number of Patients Experiencing Treatment Emergent Adverse Events.
Hide Description

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.

Time Frame at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, described as all randomized patients having received at least one dose of study medication
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 216 222
Measure Type: Number
Unit of Measure: Participants
101 112
3.Secondary Outcome
Title H. Pylori Eradication and Presence or Past History of Peptic Ulcers
Hide Description 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.
Time Frame Week 6 and week 10 follow-up visits
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population.
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 19 18
Measure Type: Number
Unit of Measure: Participants
18 15
4.Secondary Outcome
Title Clarithromycin Resistance
Hide Description 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
Time Frame Measured at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis population
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 33 25
Measure Type: Number
Unit of Measure: participants
30 2
5.Secondary Outcome
Title Metronidazole Resistance
Hide Description 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
Time Frame Measured at baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 42 41
Measure Type: Number
Unit of Measure: participants
38 28
6.Secondary Outcome
Title Overall Compliance to Study Medications
Hide Description Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population
Time Frame At the end of the treatment phase (days 8-14)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 216 218
Mean (Standard Deviation)
Unit of Measure: participants
97.58  (10.71) 97.47  (14.91)
7.Secondary Outcome
Title Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
Hide Description Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)
Time Frame Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only
Hide Outcome Measure Data
Hide Analysis Population Description
Plasma bismuth concentrations were analysed in the OBMT arm only. The goal was to determine whether bismuth plasma concentrations would be of 50 ug/l or above at end of treatment, or at the end of study. The results report the number of patients having reached 50 ug/l in the OBMT arm at either of these timepoints.
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description:
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)
Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
Overall Number of Participants Analyzed 216 0
Measure Type: Number
Unit of Measure: participants
0
Time Frame Adverse events were recorded starting at the signing of the informed consent until the final visit (Day 70) or early withdrawal visit. Serious adverse events were followed until 30 days after the patient had stopped study participation.
Adverse Event Reporting Description Systematic assessment done for laboratory evaluations and bismuth plasma levels.
 
Arm/Group Title Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Hide Arm/Group Description 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) Omeprazole 20 mg BID, Amoxicillin 500 mg 2 capsules BID and Clarithromycin 500 mg 1 tablet BID
All-Cause Mortality
Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/216 (1.85%)      3/222 (1.35%)    
Cardiac disorders     
Ventricular extrasystoles * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Gastrointestinal disorders     
Pancreatitis * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Vomiting * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
General disorders     
Condition aggravated * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Pyrexia * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Infections and infestations     
Appendicitis * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Proteus infection * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
e coli urinary tract infection * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Malnutrition * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastrointestinal carcinoma * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
Nervous system disorders     
Vascular dementia * 1  0/216 (0.00%)  0 1/222 (0.45%)  1
Psychiatric disorders     
Schizophrenia * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
Renal and urinary disorders     
Renal artery stenosis * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
Renal failure acute * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
Skin and subcutaneous tissue disorders     
Eczema * 1  1/216 (0.46%)  1 0/222 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, PT
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quadruple Therapy (OBMT) 10 Days Triple Therapy (OAC) 7 Days
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/216 (45.37%)      105/222 (47.30%)    
Gastrointestinal disorders     
Dyspepsia * 1  22/216 (10.19%)  30/222 (13.51%) 
Diarrhea * 1  14/216 (6.48%)  28/222 (12.61%) 
Nausea * 1  14/216 (6.48%)  2/222 (0.90%) 
Headache * 1  18/216 (8.33%)  7/222 (3.15%) 
Nervous system disorders     
Dysgeusia * 1  12/216 (5.56%)  22/222 (9.91%) 
Vascular disorders     
Abdominal pain upper * 1  18/216 (8.33%)  16/222 (7.21%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, PT
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.
Restrictions vary in accordance with the agreement with investigators. Axcan will allow publication after a multi-centre publication or after an agreed period, subject to review by Axcan for confidentiality and intellectual protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Monique Giguere, PhD, Programs Director,
Organization: Axcan Pharma Inc.
Phone: 1-800-565-3255 ext 2078
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00669955    
Other Study ID Numbers: PYLHp07-01
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: June 21, 2010
Results First Posted: August 5, 2010
Last Update Posted: March 16, 2017