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NCT00169013 Clinical Trial

Gabapentin in Phantom and Stump Pain

Amputation of Lower Limb Clinical Trial

Official title:
Gabapentin in the Prevention of Phantom Limb Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00169013
Other study ID # Gabapentin2002
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated April 11, 2007
Start date May 2002
Est. completion date June 2006

Study information
Verified date April 2007
Source Danish Pain Research Center
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

To investigate whether gabapentin can prevent phantom and stump pain after amputation.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.-

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin

Locations
Country Name City State
Denmark Danish Pain Research Center, Aarhus University Hospital Aarhus

Sponsors (2)
Lead Sponsor Collaborator
Danish Pain Research Center Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary outcome measures:
Primary Number of patients with phantom and stump pain 30 days and 6 months after amputation
Primary Average intensity of stump and phantom pain 30 days and 6 months after amputation
Secondary Secondary outcome measures:
Secondary Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
Secondary McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
Secondary Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
Secondary Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.

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