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Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260388
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE October 6, 2014
First Posted Date  ICMJE October 9, 2014
Results First Submitted Date  ICMJE March 2, 2018
Results First Posted Date  ICMJE July 6, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit [ Time Frame: 12 weeks ]
The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Change in patient-reported pain [ Time Frame: 12 weeks ]
Patients will complete a Likert-type scale for pain at each visit, the Patient Reported Outcome Measurement Information System (PROMIS) 6 item pain interference scale. Final measurement is based on the change in pain score at the end of 12 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • SF12 Health Composite Scores [ Time Frame: 12 weeks ]
    SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view. Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. Scores are calibrated so that 50 is the average score or norm, standard deviation = 10. Higher scores indicate better health for both mental and physical component summary scores.
  • PROMIS Pain Interference Short Form v1.0 8a T Score [ Time Frame: 12 weeks ]
    Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
  • PROMIS Fatigue Short Form v1.0 8a [ Time Frame: 12 Weeks ]
    Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
  • PROMIS Sleep Disturbance Short Form v1.0 8a [ Time Frame: 12 weeks ]
    Higher scores for sleep disturbance represents worse outcome (more sleep disturbance). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population. Higher scores equals more of the concept being measured
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
  • Percentage of patients who discontinue treatment [ Time Frame: Up to 12 weeks ]
  • Change in general health and well being [ Time Frame: 12 weeks ]
    Change will be measured using the SF-12 questionnaire.
  • Pain interference [ Time Frame: 12 weeks ]
    Measure of how pain and how it may interfere with multiple aspects of each participants life. Changes will be measured using the NIH Pain Interference Scale.
  • Change in Fatigue [ Time Frame: 12 Weeks ]
    Participants will complete NIH Fatigue Interference Scale at study visits. Responses will measure change in how often, how long, how intense a participant's fatigue is and how fatigue affects their life.
  • Quality of Sleep [ Time Frame: 12 weeks ]
    Participants will complete NIH Sleep Disturbance Scale at study visits. Scale measures quality and length of sleep. Outcome measured by change in scores from baseline visit to end of study/week 12 visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
Official Title  ICMJE Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)
Brief Summary The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).
Detailed Description

The goal of this research project is to find the best drug for the treatment of pain in patients with CSPN. While the pharmaceutical industry has focused attention on drugs for treating diabetic sensory neuropathy (DSPN), and two drugs are now FDA approved, there have not been any prospective trials in CSPN. And, because there are no studies with CSPN patients, insurance carriers often reject authorizing prescriptions for some drugs for patients with CSPN.

There are four drugs that will be tested in this study: nortriptyline, duloxetine, pregabalin and mexiletine. These drugs are not approved by the FDA for the treatment of CSPN and are considered "investigational" in this study.

There are two periods in this study: Screening/Baseline and Study Drug. During the Screening/Baseline period the researchers will determine eligibility for potential subjects. During the second period, eligible patients who consented to participate will take the study drug. Participants will be randomized to receive one of the four drugs in this study. Participants will know which drug they are taking. Participants will not be allowed to switch groups and receive a different drug during the study.

This study uses an adaptive study design. This means the study can enroll less participants and provide better conclusions. The study design allows the researchers the ability to make changes to the approach of the study or to stop the study early if there are strong results.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cryptogenic Sensory Polyneuropathy
Intervention  ICMJE
  • Drug: Nortriptyline
  • Drug: Duloxetine
  • Drug: Pregabalin
  • Drug: Mexiletine
Study Arms  ICMJE
  • Experimental: Nortriptyline
    Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.
    Intervention: Drug: Nortriptyline
  • Experimental: Duloxetine
    Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.
    Intervention: Drug: Duloxetine
  • Experimental: Pregabalin
    Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.
    Intervention: Drug: Pregabalin
  • Experimental: Mexiletine
    Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.
    Intervention: Drug: Mexiletine
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
402
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2014)
400
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of cryptogenic sensory polyneuropathy.
  • Likert Pain Score of greater than or equal to 4.
  • Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or similar class of medication for at least 7 days from baseline study visit.

Exclusion Criteria:

  • Any medical condition or current medication that would prevent them from taking either nortriptyline, duloxetine, pregabalin or mexiletine.
  • Unable to give consent.
  • Unable or not willing to comply with the study.
  • Other causes for polyneuropathy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02260388
Other Study ID Numbers  ICMJE STUDY00001500
PCORI-1306-02496 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Richard Barohn, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date June 2018

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