Condition category
Signs and Symptoms
Date applied
23/07/2007
Date assigned
12/09/2007
Last edited
01/05/2014
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 Dilip Kapur

ORCID ID

Contact details

Flinders Medical Centre
Pain Management Centre
Bedford Park
Adelaide
5042
Australia
Dilip.Kapur@fmc.sa.gov.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL0022

Study information

Scientific title

Acronym

Study hypothesis

The purpose of the study is to investigate the following:
1. Reported levels of pain in patients receiving nabilone for the treatment of chronic neuropathic pain for a period of one year
2. Patient tolerance of nabilone when used in the treatment of chronic neuropathic pain over a period of one year
3. Effects of nabilone on memory and psychometric function when used in the treatment of chronic neuropathic pain over a period of one year

Ethics approval

Approval received from:
1. South Tees Local Research Ethics Committee on the 26th March 2002 (ref: 00/51)
2. West Ethics Committee Glasgow on the 7th December 2001 (ref: 01/182)
3. Newcastle and North Tyneside Joint Ethics Committee on the 30th October 2001 (ref: 2000/138)

Study design

One year open label non-randomised, non-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mixed neuropathic pain

Intervention

Coming out of the cross-over trial mentioned in the inclusion criteria, patients with benefit on either of the study drugs was offered to participate in the open label trial. Nabilone capsules for oral intake were titrated in the first four weeks to 1 mg, then doubled to 2 mg if there were no side effects and then doubled again to 4 mg which was the maximum dose. The dose was then reduced to the lowest effective dose and the patient continued on this dose for one year if they did not decide to withdraw.

Intervention type

Drug

Phase

Not Specified

Drug names

Nabilone

Primary outcome measures

Mean monthly pain scores compared to baseline: Visual Analogue Scale (VAS) scores were recorded daily in a diary together with hours slept and sleep interruption. Pain score were averaged over one month and compared to baseline every three months in the analysis.

Secondary outcome measures

1. Sleep was measured as hours slept and if the sleep was interrupted or not in the diary
2. Depression and anxiety were measured with the Hospital Anxiety and Depression Score (HAD) at baseline and then every three months
3. Depression
4. Quality of life was measured with the 36-item Short Form questionnaire (SF-36) at baseline and then every three months
5. Side effects were collected monthly with the eight-point questionnaire rating the severity of the side effects on a five point scale plus a field for open comments
6. Psychometric tests performed every three months

Overall trial start date

01/10/2001

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic neuropathic pain who have previously participated in the trial entitled: 'A randomised, crossover, double blind comparison of the analgesic effect and patient tolerability of nabilone and dihydrocodeine in chronic neuropathic pain' (see ISRCTN15330757) may enter this study. As such, patients will already have satisfied criteria for the diagnosis of chronic neuropathic pain.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

90

Participant exclusion criteria

Patients may not enter the study if they have a history of any of the following conditions:
1. Epilepsy
2. Liver disease
3. Psychosis
4. Bipolar disorder
5. Substance misuse
6. Renal failure
7. Adverse reactions to nabilone
8. Pregnant women, lactating women or women of childbearing potential not using effective methods of contraception
9. Patients involved in ongoing legal action against a third party in which financial compensation is being sought for personal injury alleged to be the cause of the presenting condition

Excluded medication:
Patients may not take the following medications during the study:
1. Antipsychotic drugs
2. Benzodiazepine drugs (excepting stable doses of night-time sedatives)
3. Monoamine oxidase inhibitors

Patients taking cannabinoid preparations of any kind may not be included in the study.

Recruitment start date

01/10/2001

Recruitment end date

01/01/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Flinders Medical Centre
Adelaide
5042
Australia

Sponsor information

Organisation

Cambridge Laboratories Ltd (UK)

Sponsor details

Deltic House Newcastle
Kingfisher Way
Silverlink Business Park
Wallsend
NE28 9NX
United Kingdom

Sponsor type

Industry

Website

http://www.camb-labs.com/index.html

Funders

Funder type

Industry

Funder name

Cambridge Laboratories Ltd (UK) - supported by a grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The sponsors/funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

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

Publication citations

Additional files

Editorial Notes