Gabapentin in Phantom and Stump Pain

This study has been completed.

First Received on September 9, 2005. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Gabapentin in the Prevention of Phantom Limb Pain

Resource links provided by NLM:

Drug Information available for: Gabapentin Gabapentin enacarbil

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

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

Additional relevant MeSH terms:

Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012