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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR852 |
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Date of registration:
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27/12/2006 |
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Primary sponsor: |
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Public title:
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Pregabalin in Patients with Central neuropathic pain: A randomized, double-blind, placebo-controlled trial of a flexible-dose regimen.
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Scientific title:
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Pregabalin in Patients with Central neuropathic pain: A randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. - N/A |
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Date of first enrolment:
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1/1/2006 |
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Target sample size:
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40 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=852 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Triple; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Jan H.
Vranken |
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Address:
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Academic Medical Center (AMC), Department of Anesthesiologie,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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Email:
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Affiliation:
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Name:
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M.R.
Kruis |
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Address:
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Academic Medical Center (AMC), Pijncentrum,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5662292 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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: burning pain, paroxysmal episodes of shooting pain, or pain on light touch. Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS) (13).
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 3 days before receiving study medication.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Central neuropathic pain
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Intervention(s)
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Pregabalin versus placebo.
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Primary Outcome(s)
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The primary efficacy parameter is a pain intensity score recorded by patients (at baseline, and 4 weeks following treatment), using a visual analog scale (VAS).
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Secondary Outcome(s)
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Health status and quality of life (QOL) questionnaires (secondary outcomes) were completed before start of treatment and 4 weeks following start of treatment. Health status and QOL measurements included the Pain Disability Index (PDI), the EQ-5D, and the Medical Outcomes Short-form Health Survey questionnaire 36 (SF36).
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Secondary ID(s)
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ISRCTN67414160
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC)
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