Gabapentin in Phantom and Stump Pain

April 11, 2007 updated by: Danish Pain Research Center

Gabapentin in the Prevention of Phantom Limb Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Pain Research Center

Collaborators

Pfizer

Investigators

  • Principal Investigator: Lone Nikolajsen, MD, PhD, Danish Pain Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 12, 2007

Last Update Submitted That Met QC Criteria

April 11, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gabapentin2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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