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

This study has been terminated.
(No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.)
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00425230
First received: January 19, 2007
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention
Chronic Phantom Limb Pain
 Drug: Duloxetine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • McGill Short Form Pain Questionairre

Secondary Outcome Measures:
  • Fiser Side effect scale
  • visual analog pain scale
  • Present Pain intensity
  • Tylenol # 3 consumption

Estimated Enrollment: 15
Study Start Date: January 2007
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425230

Locations
United States, Texas
Micheal E. DeBakey Veterans Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Asif Chaudhry, MD Baylor College of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425230     History of Changes
Other Study ID Numbers: 06J02H
Study First Received: January 19, 2007
Last Updated: December 21, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013