NCT00006427

Brief Summary

This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

Trial Health

80
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2000

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Last Updated

September 26, 2016

Status Verified

May 1, 2011

Enrollment Period

4.9 years

First QC Date

November 1, 2000

Last Update Submit

September 23, 2016

Conditions

Amputation, TraumaticPainPostoperative Pain

Keywords

AmputationChronic PainAmitriptyline

Interventions

AmitriptylineDRUG

Eligibility Criteria

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

You may qualify if:

  • Amputation six months ago or longer
  • Pain for 3 months or longer

You may not qualify if:

  • History of cardiovascular disease, seizures, or glaucoma
  • Currently taking antidepressant medications
  • Currently hyperthyroid or taking thyroid medication
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, Department of Rehabilitation Medicine

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. doi: 10.3928/0147-7447-19930601-10.

    PMID: 8321759BACKGROUND

  • Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.

    PMID: 1535121BACKGROUND

  • Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. doi: 10.1055/s-2007-1014359.

    PMID: 8127926BACKGROUND

Related Links

MeSH Terms

Conditions

Amputation, TraumaticPainPain, PostoperativeChronic Pain

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Lawrence Robinson, MD, Professor

    University of Washington, Department of Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 2000

First Posted

November 2, 2000

Study Start

August 1, 1996

Primary Completion

July 1, 2001

Last Updated

September 26, 2016

Record last verified: 2011-05

Locations

US(1)