- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425230
Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain
August 10, 2022 updated by: Wayne Goodman MD, Baylor College of Medicine
Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain
This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Micheal E. DeBakey Veterans Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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McGill Short Form Pain Questionairre
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Secondary Outcome Measures
Outcome Measure |
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Fiser Side effect scale
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visual analog pain scale
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Present Pain intensity
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Tylenol # 3 consumption
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asif Chaudhry, MD, Baylor College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Study Completion
June 1, 2007
Study Registration Dates
First Submitted
January 19, 2007
First Submitted That Met QC Criteria
January 19, 2007
First Posted (ESTIMATE)
January 22, 2007
Study Record Updates
Last Update Posted (ACTUAL)
August 12, 2022
Last Update Submitted That Met QC Criteria
August 10, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pain, Postoperative
- Phantom Limb
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- H-19539
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Phantom Limb Pain
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VA Office of Research and DevelopmentRecruitingChronic Pain | Lower Limb Amputation | Phantom Pain | Upper Limb Amputation | Phantom Limb Pain After AmputationUnited States
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Universidad de AntioquiaNot yet recruitingPain, Chronic | Phantom Limb PainColombia
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Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
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Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Lower Limb Amputation | Phantom PainRussian Federation
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United States Naval Medical Center, San DiegoUnknownPhantom Limb Pain | Phantom Pain | Phantom Sensation | PseudomeliaUnited States
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Weill Medical College of Cornell UniversityMassachusetts General HospitalRecruitingPain, Postoperative | Sensation Disorders | Pain, Chronic | Sensory Disorder | Phantom Pain | Phantom Sensation | Sensation, Phantom | Sensory Defect | NumbnessUnited States
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Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Phantom PainRussian Federation
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Academisch Medisch Centrum - Universiteit van Amsterdam...European Society of AnaesthesiologyTerminatedChronic Pain | Phantom Limb Pain | PreventionUnited States, Austria, Belgium, Netherlands, Spain
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Centre d'Investigation Clinique et Technologique...CompletedAmputation | Phantom Pain Following Amputation of Lower LimbFrance
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University of California, San DiegoCompletedPhantom Limb Pain | Residual Limb PainUnited States
Clinical Trials on Duloxetine
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Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Completed
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Boehringer IngelheimCompletedDiabetic Neuropathies | Depressive Disorder, MajorGermany
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.RecruitingMajor Depressive Disorder (MDD)China
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Completed
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University of MinnesotaHoffmann-La Roche; Minnesota Medical FoundationCompleted
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University of PittsburghEli Lilly and Company; National Institutes of Health (NIH)CompletedBack Pain | Major Depressive Disorder | AgedUnited States
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Hamilton Health Sciences CorporationSt. Joseph's Healthcare Hamilton; Eli Lilly and Company; McMaster UniversityUnknown
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New York State Psychiatric InstituteEli Lilly and CompanyCompletedDysthymic Disorder | Depressive Disorder NOSUnited States
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Boehringer IngelheimCompleted
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Eli Lilly and CompanyShionogiCompleted