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Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Blinded study medication
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis focused on measuring Clinical Trial, Phase II

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns HopkinsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Largest change from baseline on pain rating
The study will measure whether blinded study medications change pain ratings and pain sensitivity on laboratory pain tests.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2017
Last Updated
November 7, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03098563
Brief Title
Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis
Official Title
Maximizing Analgesia to Reduce Pain Sensitivity in Chronic Knee Osteoarthritis Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Clinical Trial, Phase II

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Blinded study medication
Other Intervention Name(s)
stimulants, benzodiazepines, opioids, cannabinoids, OTC medications, placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Largest change from baseline on pain rating
Description
The study will measure whether blinded study medications change pain ratings and pain sensitivity on laboratory pain tests.
Time Frame
8 hour study session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia M Campbell, Ph.D.
Phone
410-550-7989
Email
ccampb41@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia M Campbell, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kelly E Dunn, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim Stone
Phone
410-550-7906
Email
jstone8@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis

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