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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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00169013 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Gabapentin in Phantom and Stump Pain
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Scientific title:
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Gabapentin in the Prevention of Phantom Limb Pain |
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Date of first enrolment:
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May 2002 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00169013 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Lone Nikolajsen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Danish Pain Research Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Amputation of crus or femur
Exclusion Criteria:
1. Patients who cannot cooperate
2. Fertile women without sufficient contraceptives
3. Allergy to gabapentin
4. Earlier amputation of the same limb except toes
5. Serious lever, kidney, cardiac, respiratory, haematological disease.-
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amputation of Lower Limb
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Intervention(s)
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Drug: Gabapentin
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Primary Outcome(s)
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Average intensity of stump and phantom pain 30 days and 6 months after amputation
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Number of patients with phantom and stump pain 30 days and 6 months after amputation
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Primary outcome measures:
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Secondary Outcome(s)
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Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
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Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
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McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
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Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
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Secondary outcome measures:
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Secondary ID(s)
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Gabapentin2002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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