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Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03098563
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date February 21, 2019
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
Largest change from baseline on pain rating [ Time Frame: 8 hour study session ]
The study will measure whether blinded study medications change pain ratings and pain sensitivity on laboratory pain tests.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
Largest change from baseline on pain rating [ Time Frame: 8 hour study session ]
The study will measure whether blinded study medications change VAS pain ratings and pain sensitivity on laboratory pain tests.
Change History Complete list of historical versions of study NCT03098563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis
Official Title  ICMJE Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
Brief Summary This research is being done to evaluate whether combining medications that are FDA approved, but have not yet been approved for combination treatment, can be effective in reducing pain.
Detailed Description This study will evaluate whether a combination of pharmacotherapies can effectively alleviate pain. Subjects will complete two screening sessions before completing four study sessions that will occur once weekly. Participants will receive double blind doses of study medications the morning of each experimental session day and will undergo standardized pain testing, physical functioning assessment, blood draws, ratings of drug effects and cognitive testing.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This study will include 4 sessions. Participants will be randomly assigned to the order in which they receive one drug (or combination of drugs) per session at each study visit.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Within-subjects design. Two pills will be administered at each study visit. Participants and study staff will be blind to the drug(s) administered.
Primary Purpose: Basic Science
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Drug: Blinded study medication
Blinded study medication: This is a double-blind within-subject Phase II trial. Study medications will remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications or placebo (sugar pill). All subjects will serve as their own control. Study medication administration will be randomized within each participant.
Other Name: stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Blinded study medication. This is a within-subject study so all session procedures will be identical. The specific medications administered that study day will be the only change each session. Study days will last approximately 8 hours and will be conducted on an outpatient basis. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
    Intervention: Drug: Blinded study medication
  • Experimental: Arm 2
    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
    Intervention: Drug: Blinded study medication
  • Experimental: Arm 3
    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
    Intervention: Drug: Blinded study medication
  • Experimental: Arm 4
    Blinded study medication. Participants will be asked to complete standardized pain testing procedures, do brief physical functioning testing, undergo blood draws and complete questionnaires and cognitive testing at multiple points over the course of each study visit.
    Intervention: Drug: Blinded study medication
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: March 27, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of knee osteoarthritis
  • Urine sample tests negative for common illicit substances of abuse (e.g., cannabis)
  • Medically cleared to take study medications
  • Are not pregnant or breast feeding
  • Willing to comply with the study protocol.

Exclusion Criteria:

  • Pain other than Knee Osteoarthritis
  • Taking opioids for pain
  • Prescribed and taking gabapentinoid, Tricyclic Antidepressants (TCA), venlafaxine, duloxetine, stimulants or benzodiazepines
  • Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
  • Known allergy to the blinded study medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claudia M Campbell, Ph.D. 410-550-7989 ccampb41@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098563
Other Study ID Numbers  ICMJE IRB00125605
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Claudia M Campbell, Ph.D. Johns Hopkins University
Principal Investigator: Kelly E Dunn, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2019

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