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| [ Print-friendly version ] |
| A one year open label assessment of the use of nabilone in the treatment of chronic neuropathic pain |
| ISRCTN | ISRCTN38408594 |
| ClinicalTrials.gov identifier | |
| Public title | A one year open label assessment of the use of nabilone in the treatment of chronic neuropathic pain |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | CL0022 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Mixed neuropathic pain |
| Participants - 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. |
| Participants - 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. |
| Anticipated start date | 01/10/2001 |
| Anticipated end date | 01/01/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 90 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
Cambridge Laboratories Ltd (UK) - supported by a grant
The sponsors/funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. |
| Trial website | |
| Publications | |
| Contact name | Dr Dilip Kapur |
| Address |
Flinders Medical Centre
Pain Management Centre Bedford Park |
| City/town | Adelaide |
| Zip/Postcode | 5042 |
| Country | Australia |
| Dilip.Kapur@fmc.sa.gov.au | |
| Sponsor | Cambridge Laboratories Ltd (UK) |
| Address |
Deltic House Newcastle
Kingfisher Way Silverlink Business Park |
| City/town | Wallsend |
| Zip/Postcode | NE28 9NX |
| Country | United Kingdom |
| Sponsor website: | http://www.camb-labs.com/index.html |
| Date applied | 23/07/2007 |
| Last edited | 12/09/2007 |
| Date ISRCTN assigned | 12/09/2007 |
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