Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR852; 1
Study information
Scientific title
Acronym
Study hypothesis
We tested, in a randomised, double-blind, placebo-controlled trial, the effects of pregabalin on pain relief, tolerability, health status, and quality of life in patients with central neuropathic pain.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, triple blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Central neuropathic pain
Intervention
Pregabalin versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Pregabalin
Primary outcome measures
The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and four weeks following treatment), using a Visual Analog Scale (VAS).
Secondary outcome measures
Health status and Quality of Life (QOL) questionnaires (secondary outcomes) were completed before start of treatment and four weeks following start of treatment.
Health status and QOL measurements included the Pain Disability Index (PDI), the EuroQoL questionnaire (EQ-5D), and the Medical Outcomes Short-Form Health Survey questionnaire 36 (SF 36).
Overall trial start date
01/01/2006
Overall trial end date
30/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18 years or older
2. Written informed consent
3. Patients suffering from severe neuropathic pain caused by lesion or dysfunction in the central nervous system. Neuropathic pain was described by at least one of the following:
a. burning pain
b. paroxysmal episodes of shooting pain
c. pain on light touch
Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Pregnant
2. Had a history of intolerance, hypersensitivity, or known allergy to pregabalin
3. Had a known history of significant hepatic, renal, or psychiatric disorder
4. Had a history of galactose-intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome
5. Subjects with a calculated creatinine clearance rate below 60 mL/m (estimated from serum creatinine using Cockroft-Gault equation) were specifically excluded
6. No new analgesic therapies were to be initiated at any time during the trial
7. Patients who had been exposed previously to gabapentin, regardless of dose and treatment duration, were permitted to enter the study. However, treatment with gabapentin was to be discontinued at least three days before receiving study medication
Recruitment start date
01/01/2006
Recruitment end date
30/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (Netherlands)
Sponsor details
Department of Anesthesiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/17703885
Publication citations
-
Results
Vranken JH, Dijkgraaf MG, Kruis MR, van der Vegt MH, Hollmann MW, Heesen M, Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen., Pain, 2008, 136, 1-2, 150-157, doi: 10.1016/j.pain.2007.06.033.