Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1

ISRCTN ISRCTN84121379
DOI https://doi.org/10.1186/ISRCTN84121379
Secondary identifying numbers N/A
Submission date
07/06/2004
Registration date
08/06/2004
Last edited
12/09/2011
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 Wim E.J. Weber
Scientific

Department of Neurology
University Hospital Maastricht
PO Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3875117
Email wweb@neurologie.azm.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedComplex Regional Pain Syndrome (CRPS)
InterventionGabapentin versus placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Gabapentin
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date19/11/1998
Completion date02/12/1999

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants58
Key inclusion criteria1. Patients with Complex Regional Pain Syndrome (CRPS)
2. With pain Visual Analogue Scale (VAS) greater than 3
3. Have undergone sympathetic blocks, mannitol infusions and Transcutaneous Electrical Nerve Stimulation (TENS) without success
Key exclusion criteriaNot provided at time of registration
Date of first enrolment19/11/1998
Date of final enrolment02/12/1999

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Department of Neurology
Maastricht
6202 AZ
Netherlands

Sponsor information

University Hospital Maastricht (The Netherlands) - Pain Centre
Hospital/treatment centre

PO Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3877498
Email sre@sane.azm.nl
ROR logo "ROR" https://ror.org/02d9ce178

Funders

Funder type

Hospital/treatment centre

University Hospital Maastricht (The Netherlands) - Pain Centre

No information available

Parke-Davis Nederland (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 29/09/2004 Yes No