Gabapentin in Phantom and Stump Pain

Overview[ - collapse ][ - ]

Purpose To investigate whether gabapentin can prevent phantom and stump pain after amputation.
ConditionAmputation of Lower Limb
InterventionDrug: Gabapentin
PhasePhase 4
SponsorDanish Pain Research Center
Responsible PartyDanish Pain Research Center
ClinicalTrials.gov IdentifierNCT00169013
First ReceivedSeptember 9, 2005
Last UpdatedApril 11, 2007
Last verifiedApril 2007

Tracking Information[ + expand ][ + ]

First Received DateSeptember 9, 2005
Last Updated DateApril 11, 2007
Start DateMay 2002
Estimated Primary Completion DateJune 2006
Current Primary Outcome Measures
  • Primary outcome measures:
  • Number of patients with phantom and stump pain 30 days and 6 months after amputation
  • Average intensity of stump and phantom pain 30 days and 6 months after amputation
Current Secondary Outcome Measures
  • Secondary outcome measures:
  • Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
  • McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
  • Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
  • Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.

Descriptive Information[ + expand ][ + ]

Brief TitleGabapentin in Phantom and Stump Pain
Official TitleGabapentin in the Prevention of Phantom Limb Pain
Brief Summary
To investigate whether gabapentin can prevent phantom and stump pain after amputation.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
ConditionAmputation of Lower Limb
InterventionDrug: Gabapentin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated EnrollmentNot Provided
Estimated Completion DateJune 2006
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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.-
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesDenmark

Administrative Information[ + expand ][ + ]

NCT Number NCT00169013
Other Study ID NumbersGabapentin2002
Has Data Monitoring CommitteeYes
Information Provided ByDanish Pain Research Center
Study SponsorDanish Pain Research Center
CollaboratorsPfizer
Investigators Principal Investigator: Lone Nikolajsen, MD, PhD Danish Pain Research Center
Verification DateApril 2007

Locations[ + expand ][ + ]

Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000