A randomised, placebo controlled trial of prednisone in early Henoch Schonlein Purpura
| ISRCTN | ISRCTN85109383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85109383 |
| Protocol serial number | 95/25S(E) |
| Sponsor | Children's Hospital of Eastern Ontario Research Institute (CHEORI) (Canada) |
| Funder | Children's Hospital of Eastern Ontario Research Institute (CHEORI) (Canada) (ref: 95/25S[E]) |
- Submission date
- 08/03/2004
- Registration date
- 09/03/2004
- Last edited
- 24/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adam Huber
Scientific
Scientific
IWK Health Centre
5850 University Avenue
Halifax
B3J 3G9
Canada
| Phone | +1 902 470 8827 |
|---|---|
| adamtheresa@hfx.eastlink.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Prednisone |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 31/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/1996 |
| Date of final enrolment | 31/01/2000 |
Locations
Countries of recruitment
- Canada
Study participating centre
IWK Health Centre
Halifax
B3J 3G9
Canada
B3J 3G9
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 02/04/2004 | Yes | No |
