Gabapentin in Phantom and Stump Pain
Overview[ - collapse ][ - ]
Purpose | To investigate whether gabapentin can prevent phantom and stump pain after amputation. |
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Condition | Amputation of Lower Limb |
Intervention | Drug: Gabapentin |
Phase | Phase 4 |
Sponsor | Danish Pain Research Center |
Responsible Party | Danish Pain Research Center |
ClinicalTrials.gov Identifier | NCT00169013 |
First Received | September 9, 2005 |
Last Updated | April 11, 2007 |
Last verified | April 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | September 9, 2005 |
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Last Updated Date | April 11, 2007 |
Start Date | May 2002 |
Estimated Primary Completion Date | June 2006 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Gabapentin in Phantom and Stump Pain |
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Official Title | Gabapentin in the Prevention of Phantom Limb Pain |
Brief Summary | To investigate whether gabapentin can prevent phantom and stump pain after amputation. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Amputation of Lower Limb |
Intervention | Drug: Gabapentin |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | June 2006 |
Estimated Primary Completion Date | Not 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.- |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Denmark |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00169013 |
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Other Study ID Numbers | Gabapentin2002 |
Has Data Monitoring Committee | Yes |
Information Provided By | Danish Pain Research Center |
Study Sponsor | Danish Pain Research Center |
Collaborators | Pfizer |
Investigators | Principal Investigator: Lone Nikolajsen, MD, PhD Danish Pain Research Center |
Verification Date | April 2007 |
Locations[ + expand ][ + ]
Danish Pain Research Center, Aarhus University Hospital | Aarhus, Denmark, 8000 |
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