Condition category
Signs and Symptoms
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
06/07/2009
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 M R Kruis

ORCID ID

Contact details

Academic Medical Center (AMC)
Pijncentrum
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

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

http://www.amc.uva.nl/

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

  1. 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.

Additional files

Editorial Notes