Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

This study is currently recruiting participants.
Verified May 2013 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01265069
First received: December 10, 2010
Last updated: May 31, 2013
Last verified: May 2013

December 10, 2010
May 31, 2013
November 2010
June 2013   (final data collection date for primary outcome measure)
to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Same as current
Complete list of historical versions of study NCT01265069 on ClinicalTrials.gov Archive Site
to compare the adverse effects and patient adherence of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
The safety and tolerability will be evaluated by the number of participant with adverse events and patient adherence (by counting unused medication after the treatment and record symptoms in a diary card).
Same as current
Not Provided
Not Provided
 
Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy
Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.

The aims of this study are:

  1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication;
  2. to compare the patient adherence and adverse effects of these treatment regimens;
  3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Patients, aged 18, having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP)2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A and B.

If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:

group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient Clinic to investigate patient adherence and adverse effects of treatment.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori Infection
  • Drug: high dose dual therapy
    rabeprazole 20mg qid,amoxicillin 750mg qid for 14days
  • Drug: concomitant therapy
    rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days
  • Active Comparator: high dose dual therapy
    Group A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days)
    Intervention: Drug: high dose dual therapy
  • Experimental: concomitant therapy
    Group B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 days).
    Intervention: Drug: concomitant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
204
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy.

Exclusion Criteria:

  • pregnant or nursing woman
  • serious concomitant illness and malignant tumor of any kind
  • history of hypersensitivity to test drugs
  • serious bleeding during the course of this ulcer
  • previous gastric surgery
  • receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.
Both
18 Years and older
No
Contact: Jyh-Chin Yang, M.D.Ph.D 886-2-23123456 ext 65055 jcyang47@ntu.edu.tw
Taiwan
 
NCT01265069
201005064M
No
National Taiwan University Hospital
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: Jyh-Chin Yang, M.D.Ph.D. National Taiwan University Hospital
National Taiwan University Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP