NCT00425230

Brief Summary

This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

First QC Date

January 19, 2007

Last Update Submit

August 10, 2022

Conditions

Chronic Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

  • McGill Short Form Pain Questionairre

Secondary Outcomes (4)

  • Fiser Side effect scale

  • visual analog pain scale

  • Present Pain intensity

  • Tylenol # 3 consumption

Interventions

DuloxetineDRUG

Eligibility Criteria

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

You may qualify if:

  • Chronic PLP \> 6 months
  • Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
  • Age ≥ 18 years old
  • Inpatient or Outpatient
  • Able to come to all appointments, in the opinion of the investigator
  • Able to give informed consent, in opinion of investigator

You may not qualify if:

  • Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
  • Substance abuse or dependence within the last six months, as assessed by the MINI
  • Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
  • History of coronary artery disease, hepatic disease, renal disease
  • Other pain syndromes
  • Any unstable medical conditions in the opinion of the investigator
  • Other psychotropic medications excluding hypnotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Micheal E. DeBakey Veterans Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Asif Chaudhry, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair/Professor

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 22, 2007

Study Start

January 1, 2007

Study Completion

June 1, 2007

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

US(1)