We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gabapentin in Phantom and Stump Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169013
First Posted: September 15, 2005
Last Update Posted: April 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Danish Pain Research Center
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00169013     History of Changes
Other Study ID Numbers: Gabapentin2002
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: April 12, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents