NCT00467571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 3, 2013

Status Verified

September 1, 2008

Enrollment Period

2.5 years

First QC Date

April 27, 2007

Last Update Submit

May 1, 2013

Conditions

Chronic Idiopathic Thrombocytopenic PurpuraHelicobacter Pylori Infection

Keywords

chronic idiopathic thrombocytopenic purpuraHelicobacter pylori infectionplatelet

Outcome Measures

Primary Outcomes (1)

  • platelet count

    6 months

Secondary Outcomes (2)

  • platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)

    6 months

  • platelet count

    6 months

Study Arms (1)

I

EXPERIMENTAL

Drug: lansoprazole, clarithromycin, amoxycillin

Drug: lansoprazole, clarithromycin, amoxycillin

Interventions

lansoprazole, clarithromycin, amoxycillinDRUG

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

Also known as: lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamox
I

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients who had a previous treatment for H. pylori infection.
  • Patients require prednisolone more than 0.5 mg/kg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Interventions

LansoprazoleClarithromycinAmoxicillin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingErythromycinMacrolidesPolyketidesLactonesAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmides

Study Officials

  • Suporn Treepongkaruna, M.D.

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

March 1, 2006

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

May 3, 2013

Record last verified: 2008-09

Locations

TH(1)