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Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura

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: NCT00467571
Recruitment Status : Completed
First Posted : April 30, 2007
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
Ramathibodi Hospital
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE April 27, 2007
First Posted Date  ICMJE April 30, 2007
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE March 2006
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
platelet count [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
Platelet count after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00467571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2008)
  • platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori) [ Time Frame: 6 months ]
  • platelet count [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Official Title  ICMJE Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Brief Summary Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.
Detailed Description Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Idiopathic Thrombocytopenic Purpura
  • Helicobacter Pylori Infection
Intervention  ICMJE Drug: lansoprazole, clarithromycin, amoxycillin
lansoprazole (15, 30 mg) 1 tab twice daily, clarithromycin 7.5 mg/kg twice daily, amoxycillin 25 mg/kg twice daily; rout: orally; duration 14 days
Other Names:
  • lansoprazole or Prevacid
  • clarithromycin or Klacid
  • Amoxycillin or Ibiamox
Study Arms  ICMJE Experimental: I
Drug: lansoprazole, clarithromycin, amoxycillin
Intervention: Drug: lansoprazole, clarithromycin, amoxycillin
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: April 27, 2007)
26
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes.
  • 13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection.

Exclusion Criteria:

  • Patients who had a previous treatment for H. pylori infection.

    • Patients require prednisolone more than 0.5 mg/kg/day
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467571
Other Study ID Numbers  ICMJE ID11-48-20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Ramathibodi Hospital
Investigators  ICMJE
Principal Investigator: Suporn Treepongkaruna, M.D. Faculty of Medicine, Ramathibodi Hospital, Mahidol University
PRS Account Mahidol University
Verification Date September 2008

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