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.)
Information provided by:
Baylor College of Medicine Identifier:
First received: January 19, 2007
Last updated: December 21, 2010
Last verified: December 2010
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:

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

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

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
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Please refer to this study by its identifier: NCT00425230

United States, Texas
Micheal E. DeBakey Veterans Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Principal Investigator: Asif Chaudhry, MD Baylor College of Medicine
  More Information 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
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms
Duloxetine Hydrochloride
Antidepressive Agents
Dopamine Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin and Noradrenaline Reuptake Inhibitors processed this record on May 25, 2016