Amitriptyline to relieve pain in juvenile idiopathic arthritis: a pilot study using Bayesian meta-analysis of multiple N-of-1 clinical trials
| ISRCTN | ISRCTN95255919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95255919 |
| Protocol serial number | 77986 |
| Sponsor | IWK Health Centre (Canada) |
| Funder | The Canadian Institutes of Health Research (Canada) (ref: 77986) - the funding for this trial predates the transition of the major public funding body in Canada from the Medical Research Council to the Canadian Institutes of Health Research. |
- Submission date
- 29/05/2006
- Registration date
- 14/07/2006
- Last edited
- 01/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
B3K 6R8
Canada
| Phone | +1 902 470 8827 |
|---|---|
| adam.huber@iwk.nshealth.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized, placebo-controlled, double-blind, multiple crossover design |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. Serial N-of-1 trials analyzed using Bayesian methods can be used to estimate population effects of interventions 2. Amitriptyline will reduce pain in children with polyarticular course juvenile idiopathic arthritis, as compared to placebo |
| Ethics approval(s) | Research Ethics Board at Sick Kids Hospital in Toronto, as well as the Research Ethics Board at the IWK Health Centre in Halifax, Nova Scotia both approved this study in September 1999 |
| Health condition(s) or problem(s) studied | Juvenile idiopathic arthritis |
| Intervention | Amitriptyline 25 mg every hour of sleep (qhs) for two weeks per treatment period versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amitriptyline |
| Primary outcome measure(s) |
Pain (measured with 6-10 cm visual analogue scale [VAS] over two days) |
| Key secondary outcome measure(s) |
1. Sleep |
| Completion date | 01/01/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 8 |
| Key inclusion criteria | 1. Aged 10-18 years of age 2. Polyarticular course juvenile idiopathic arthritis 3. At least one active joint 4. Minimum pain score of 1 cm |
| Key exclusion criteria | Prolonged QT interval |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 01/01/2002 |
Locations
Countries of recruitment
- Canada
Study participating centre
IWK Health Centre
Halifax
B3K 6R8
Canada
B3K 6R8
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 | 01/05/2007 | Yes | No |
