Condition category
Musculoskeletal Diseases
Date applied
29/05/2006
Date assigned
14/07/2006
Last edited
01/10/2008
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
B3K 6R8
Canada
+1 902 470 8827
adam.huber@iwk.nshealth.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

77986

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Randomized, placebo-controlled, double-blind, multiple crossover design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Amitriptyline

Primary outcome measures

Pain (measured with 6-10 cm visual analogue scale [VAS] over two days)

Secondary outcome measures

1. Sleep
2. Stiffness
3. Physical function
4. Active and swollen joint counts
5. Fatigue

Overall trial start date

01/10/1999

Overall trial end date

01/01/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

8

Participant exclusion criteria

Prolonged QT interval

Recruitment start date

01/10/1999

Recruitment end date

01/01/2002

Locations

Countries of recruitment

Canada

Trial participating centre

IWK Health Centre
Halifax
B3K 6R8
Canada

Sponsor information

Organisation

IWK Health Centre (Canada)

Sponsor details

5850 University Avenue
Halifax
B3K 6R8
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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.

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17444584

Publication citations

  1. Results

    Huber AM, Tomlinson GA, Koren G, Feldman BM, Amitriptyline to relieve pain in juvenile idiopathic arthritis: a pilot study using Bayesian metaanalysis of multiple N-of-1 clinical trials., J. Rheumatol., 2007, 34, 5, 1125-1132.

Additional files

Editorial Notes