Condition category
Musculoskeletal Diseases
Date applied
07/06/2004
Date assigned
08/06/2004
Last edited
12/09/2011
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 Wim E.J. Weber

ORCID ID

Contact details

Department of Neurology
University Hospital Maastricht
PO Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3875117
wweb@neurologie.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Complex Regional Pain Syndrome (CRPS)

Intervention

Gabapentin versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Gabapentin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/11/1998

Overall trial end date

02/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

58

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

19/11/1998

Recruitment end date

02/12/1999

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Neurology
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

University Hospital Maastricht (The Netherlands) - Pain Centre

Sponsor details

PO Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3877498
sre@sane.azm.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Maastricht (The Netherlands) - Pain Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Parke-Davis Nederland (The Netherlands)

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

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15453912

Publication citations

  1. Results

    van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE, Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]., BMC Neurol, 2004, 4, 13, doi: 10.1186/1471-2377-4-13.

Additional files

Editorial Notes