NCT00169013

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 9, 2024

Status Verified

April 1, 2007

First QC Date

September 9, 2005

Last Update Submit

August 8, 2024

Conditions

Amputation of Lower Limb

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • 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.

Interventions

GabapentinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Amputation of crus or femur

You may not qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Lone Nikolajsen, MD, PhD

    Danish Pain Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

May 1, 2002

Study Completion

June 1, 2006

Last Updated

August 9, 2024

Record last verified: 2007-04

Locations

DK(1)