Chronic Idiopathic Thrombocytopenic PurpuraPhase 4NCT00467571
Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
A Phase 4 study testing lansoprazole, clarithromycin, amoxycillin in people with Chronic Idiopathic Thrombocytopenic Purpura and Helicobacter Pylori Infection, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chronic Idiopathic Thrombocytopenic Purpura, Helicobacter Pylori Infection
- What is being tested?
- lansoprazole, clarithromycin, amoxycillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2006to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients who had a previous treatment for H. pylori infection.
- Patients require prednisolone more than 0.5 mg/kg/day
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Bangkok, Bangkok, 10400
About this study
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.
Read the 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.
- Being tested
- lansoprazole, clarithromycin, amoxycillin
- Keywords
- chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lansoprazole, clarithromycin, amoxycillinDrug
Also called lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamox
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
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Drug: lansoprazole, clarithromycin, amoxycillin Receives: Drug: lansoprazole, clarithromycin, amoxycillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet count
Measured: 6 months
Secondary outcomes (2)
platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)
Measured: 6 months
platelet count
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startMar 2006
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor
- Investigators
- Suporn Treepongkaruna, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467571
- Sponsor's protocol ID
- ID11-48-20
- Status last verified
- Sep 2008
- First submitted
- 27 Apr 2007
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00467571
- Acronym / sponsor ID
- ID11-48-20
- Keywords
- chronic idiopathic thrombocytopenic purpura, Helicobacter pylori infection, platelet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- Mar 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: lansoprazole, clarithromycin, amoxycillinDrug: lansoprazole, clarithromycin, amoxycillin |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who had a previous treatment for H. pylori infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lansoprazole, clarithromycin, amoxycillinAlso: lansoprazole or Prevacid, clarithromycin or Klacid, Amoxycillin or Ibiamoxlansoprazole (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 | Drug | I |
Primary outcome
platelet count
Time frame: 6 months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
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RecruitingPhase 2/3
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Immune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia
RecruitingObservational study
Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suporn Treepongkaruna, M.D. principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lansoprazole, clarithromycin, amoxycillin in people with Chronic Idiopathic Thrombocytopenic Purpura and Helicobacter Pylori Infection, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.