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Trial record 4 of 47 for:    DESIPRAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date September 24, 2018
Actual Study Start Date  ICMJE September 20, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Pain Intensity [ Time Frame: Monthly for 6 months ]
Average and worst pain intensity reported by participants on a numerical rating scale of 0-10
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03548454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Physical Function [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function
  • Pain Interference [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference
  • Depression [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression
  • Anxiety [ Time Frame: Monthly for 6 months ]
    National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety
  • Adherence [ Time Frame: Monthly for 6 months ]
    Time to stopping either medication in days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Official Title  ICMJE Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: Duloxetine
    Open label prescription
    Other Name: Cymbalta
  • Drug: Desipramine
    Open label prescription
    Other Name: Norpramin
Study Arms  ICMJE
  • Experimental: Duloxetine
    Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
    Intervention: Drug: Duloxetine
  • Experimental: Desipramine
    Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.
    Intervention: Drug: Desipramine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2018)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vafi Salmasi, MD. 650-725-0246 vsalmasi@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548454
Other Study ID Numbers  ICMJE 44758
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vafi Salmasi, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vafi Salmasi, MD. Stanford University
PRS Account Stanford University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP