Gabapentin in Phantom and Stump Pain

This study has been completed.

First Received: September 9, 2005 Last Updated: April 11, 2007 History of Changes

Sponsor:	Danish Pain Research Center
Collaborator:	Pfizer
Information provided by:	Danish Pain Research Center
ClinicalTrials.gov Identifier:	NCT00169013

Purpose

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

Condition	Intervention	Phase
Amputation of Lower Limb	Drug: Gabapentin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Gabapentin in the Prevention of Phantom Limb Pain

Resource links provided by NLM:

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by Danish Pain Research Center:

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

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.

Study Start Date:	May 2002
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Amputation of crus or femur

Exclusion Criteria:

Patients who cannot cooperate
Fertile women without sufficient contraceptives
Allergy to gabapentin
Earlier amputation of the same limb except toes
Serious lever, kidney, cardiac, respiratory, haematological disease.-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169013

Locations

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

Sponsors and Collaborators

Danish Pain Research Center

Pfizer

Investigators

Principal Investigator:

Lone Nikolajsen, MD, PhD

Danish Pain Research Center

More Information

Additional Information:

Danish Pain Research Center This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	Gabapentin2002
Study First Received:	September 9, 2005
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00169013 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on February 08, 2010