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Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

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ClinicalTrials.gov Identifier: NCT03548454
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Vafi Salmasi, Stanford University

Brief Summary:
Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Duloxetine Drug: Desipramine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Duloxetine
Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
Drug: Duloxetine
Open label prescription
Other Name: Cymbalta

Experimental: Desipramine
Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
Drug: Desipramine
Open label prescription
Other Name: Norpramin




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Monthly for 6 months ]
    Average and worst pain intensity reported by participants on a numerical rating scale of 0-10


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function

  2. Pain Interference [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference

  3. Depression [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression

  4. Anxiety [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety

  5. Adherence [ Time Frame: Monthly for 6 months ]
    Time to stopping either medication in days



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:   No
Criteria

Inclusion criteria:

  1. Age of 18 years old or above
  2. Persistent pain for more than 3 months
  3. Candidate for treatment by anti-depressant based on treating pain provider

Exclusion criteria:

  1. Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)
  2. Contraindication to taking duloxetine or desipramine
  3. Patient refusal

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): NCT03548454


Contacts
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Contact: Vafi Salmasi, MD. 650-725-0246 vsalmasi@stanford.edu

Locations
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United States, California
Stanford Pain Management Center Recruiting
Redwood City, California, United States, 94063
Contact: Vafi Salmasi, MD.    650-725-0246    vsalmasi@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Vafi Salmasi, MD. Stanford University

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Responsible Party: Vafi Salmasi, Clinical Instructor, Stanford University
ClinicalTrials.gov Identifier: NCT03548454     History of Changes
Other Study ID Numbers: 44758
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Desipramine
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
Antidepressive Agents, Tricyclic
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents