Gabapentin in Phantom and Stump Pain

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT00169013
First received: September 9, 2005
Last updated: April 11, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Amputation of Lower Limb
Drug: Gabapentin
Phase 4

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:


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:

  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.-
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 20, 2014