Condition category
Haematological Disorders
Date applied
08/03/2004
Date assigned
09/03/2004
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adam Huber

ORCID ID

Contact details

IWK Health Centre
5850 University Avenue
Halifax
B3J 3G9
Canada
+1 902 470 8827
adamtheresa@hfx.eastlink.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

95/25S(E)

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Henoch Schonlein Purpura

Intervention

Intervention:
Prednisone 2 mg/kg for 7 days, 75% on days 8 and 9, 50% on days 10 and 11 and 25% on days 12, 13, 14, then stopped.

Control:
Comparison group was an identical appearing placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Prednisone

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1996

Overall trial end date

31/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Eligible participants were children between the ages of 2 and 15, presenting to the emergency room within 7 days of onset of Henoch Schonlein Purpura.

Children were excluded if:
1. Another explanation for purpura was present
2. They had a known underlying systemic vasculitis
3. They had been treated with any form of corticosteroids in the preceding month
4. They had a known chronic illness affecting the renal, gastrointestinal or immune systems
5. They had an active infection
6. They were experiencing a life-threatening complication of Henoch Schonlein Purpura

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1996

Recruitment end date

31/01/2000

Locations

Countries of recruitment

Canada

Trial participating centre

IWK Health Centre
Halifax
B3J 3G9
Canada

Sponsor information

Organisation

Children's Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)

Sponsor details

401 Smyth Road
Room 139
Ottawa
K1H 8L1
Canada
+1 613 737 7600 ext. 2686
brazeau@cheo.on.ca

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Children's Hospital of Eastern Ontario Research Institute (CHEORI) (Canada) (ref: 95/25S[E])

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15059282

Publication citations

  1. Results

    Huber AM, King J, McLaine P, Klassen T, Pothos M, A randomized, placebo-controlled trial of prednisone in early Henoch Schönlein Purpura [ISRCTN85109383]., BMC Med, 2004, 2, 7, doi: 10.1186/1741-7015-2-7.

Additional files

Editorial Notes