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

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ClinicalTrials.gov Identifier: NCT00425230
Recruitment Status : Terminated (No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.)
First Posted : January 22, 2007
Last Update Posted : December 22, 2010
Sponsor:
Information provided by:
Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Chronic Phantom Limb Pain Drug: Duloxetine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain
Study Start Date : January 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. McGill Short Form Pain Questionairre

Secondary Outcome Measures :
  1. Fiser Side effect scale
  2. visual analog pain scale
  3. Present Pain intensity
  4. Tylenol # 3 consumption


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00425230     History of Changes
Other Study ID Numbers: 06J02H
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents