A randomised double-blind placebo-controlled trial to investigate the efficacy and side-effects of pregabalin for the treatment of neuropathic pain in humans following severe burn injury
| ISRCTN | ISRCTN56448626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56448626 |
| Protocol serial number | 2004/142 |
| Sponsor | Royal Brisbane and Women's Hospital (Australia) |
| Funder | Royal Brisbane and Women's Hospital Research Foundation |
- Submission date
- 03/11/2004
- Registration date
- 09/12/2004
- Last edited
- 12/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paul Gray
Scientific
Scientific
Multidisciplinary Pain Centre
Royal Brisbane and Women's Hospital
Herston, QLD
4029
Australia
| p.gray@uq.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised double-blind placebo-controlled trial to investigate the efficacy and side-effects of pregabalin for the treatment of neuropathic pain in humans following severe burn injury |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neuropathic pain following burn injury may occur in the acute or chronic state. |
| Intervention | Randomised trial of pregabalin versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | pregabalin |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients who have severe burn injuries with elements of neuropathic pain. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/01/2006 |
Locations
Countries of recruitment
- Australia
Study participating centre
Multidisciplinary Pain Centre
Herston, QLD
4029
Australia
4029
Australia
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 | 01/06/2011 | 12/01/2021 | Yes | No |
Editorial Notes
12/01/2021: Publication reference added.
