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Trial record 79 of 398 for:    CLARITHROMYCIN

The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

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: NCT02648659
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seong Woo Jeon, Kyungpook National University Hospital

Tracking Information
First Submitted Date  ICMJE January 5, 2016
First Posted Date  ICMJE January 7, 2016
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE March 2, 2016
Actual Primary Completion Date January 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
Eradication rate after tailored therapy assessed by urea breath test [ Time Frame: Test at 4 -6 weeks after completion of medication ]
After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
Number of participants with treatment-related adverse events as assessed by questionnaire [ Time Frame: Questionnaire and diary during medication for 14days ]
During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
Official Title  ICMJE The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
Brief Summary This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.
Detailed Description

This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.

The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peptic Ulcer
Intervention  ICMJE
  • Drug: Ilaprazole
    Ilaprazole 10mg 1tablet qid(4 times/day)
    Other Name: Noltec®
  • Drug: Amoxicillin
    Amoxicillin 500mg 1capsule qid(4times/day)
    Other Name: Pamoxin®
  • Drug: Clarithromycin
    Clarithromycin 500mg 1tablet bid(2times/day)
    Other Name: Clafaxin®
  • Drug: Metronidazole
    Metronidazole 250mg 2tablets tid(3times/day)
    Other Name: Flasinyl®
Study Arms  ICMJE
  • Experimental: triple with clarithromycin
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
    Interventions:
    • Drug: Ilaprazole
    • Drug: Amoxicillin
    • Drug: Clarithromycin
  • Experimental: triple with metronidazole
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
    Interventions:
    • Drug: Ilaprazole
    • Drug: Amoxicillin
    • Drug: Metronidazole
  • Experimental: quadruple
    Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
    Interventions:
    • Drug: Ilaprazole
    • Drug: Amoxicillin
    • Drug: Clarithromycin
    • Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2016)
55
Actual Study Completion Date  ICMJE February 14, 2017
Actual Primary Completion Date January 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • 20 year old ≤ Male or female < 80 year old

    • Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.
    • Subject who fully understands conditions of clinical trial
    • Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

  • Known hypersensitivity to experimental and concomitant drugs
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • Subjects with abnormal levels in the laboratory tests

    • Total Bilirubin, Creatinine> 1.5 times upper limit of normal
    • AST, ALT, Alkaline phosphatase, BUN> 2 times upper limit of normal
  • Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.
  • Pregnant and/or lactating women
  • Reproductive aged women not using contraception
  • Uncontrolled diabetics
  • Uncontrolled hypertension
  • Uncontrolled liver dysfunction
  • Alcoholics
  • Subjects with a history or possibility of digestive malignancy within 5 years
  • Subjects with a history of gastrectomy or esophagectomy
  • Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
  • Subjects participating in a clinical trial before another trial within 30 days
  • Inconsistence judged subject by researcher
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02648659
Other Study ID Numbers  ICMJE KNUMC-JSW-ILA01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seong Woo Jeon, Kyungpook National University Hospital
Study Sponsor  ICMJE Kyungpook National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seong Woo Jeon Kyungpook national university medical center
PRS Account Kyungpook National University Hospital
Verification Date August 2018

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