Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

NCT ID: NCT00425230

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Phantom Limb Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Duloxetine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Wayne Goodman MD

Chair/Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asif Chaudhry, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Micheal E. DeBakey Veterans Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-19539

Identifier Type: -

Identifier Source: org_study_id

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