Trial Outcomes & Findings for Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis (NCT NCT03098563)
NCT ID: NCT03098563
Last Updated: 2024-12-11
Results Overview
The study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
8 hour study session
Results posted on
2024-12-11
Participant Flow
Experimental Session 1 is a safety session and completed first. The remaining sessions were completed in triple blinded randomized order.
Participant milestones
| Measure |
Hydromorphone+Placebo
Within-subject double-blind, double-dummy administration of hydromorphone (oral) + placebo. Always administered during session 1. 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.
This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Placebo+Placebo
Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-4. 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.
This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Dronabinol + Placebo
Within-subject double-blind, double-dummy administration of dronabinol + placebo. Order of dose randomized session days 2-4. 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.
This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Hydromorphone + Dronabinol
Within-subject double-blind, double-dummy administration of hydromorphone + dronabinol. Order of dose randomized session days 2-4. 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.
This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
|---|---|---|---|---|
|
Experimental Session 1
STARTED
|
58
|
0
|
0
|
0
|
|
Experimental Session 1
COMPLETED
|
58
|
0
|
0
|
0
|
|
Experimental Session 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Experimental Sessions 2-4
STARTED
|
0
|
0
|
0
|
58
|
|
Experimental Sessions 2-4
COMPLETED
|
0
|
0
|
0
|
58
|
|
Experimental Sessions 2-4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximizing Analgesia to Reduce Pain in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Overall
n=58 Participants
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.
This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
|---|---|
|
Age, Continuous
|
62.34 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 hour study sessionThe study will measure whether blinded study medications change clinical pain ratings (0-100 pain rating scale). Higher score indicates worse outcome. Biggest difference from baseline over the entire session is reported.
Outcome measures
| Measure |
Placebo + Placebo
n=58 Participants
Placebo + Placebo. 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: Placebo + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Hydromorphone + Placebo
n=58 Participants
Hydromorphone + Placebo. 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: Hydromorphone + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Dronabinol + Placebo
n=58 Participants
Dronabinol + Placebo. 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: Dronabinol + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Hydromorphone + Dronabinol
n=58 Participants
Hydromorphone + Dronabinol. 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: Hydromorphone + Dronabinol. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
|---|---|---|---|---|
|
Largest Change From Baseline on Clinical Pain Rating
Baseline
|
24.19 score on a scale
Standard Deviation 23.63
|
30.48 score on a scale
Standard Deviation 27.39
|
28.55 score on a scale
Standard Deviation 26.78
|
26.38 score on a scale
Standard Deviation 25.86
|
|
Largest Change From Baseline on Clinical Pain Rating
Peak Effect
|
12.76 score on a scale
Standard Deviation 17.81
|
9.40 score on a scale
Standard Deviation 16.27
|
12.80 score on a scale
Standard Deviation 17.50
|
12.41 score on a scale
Standard Deviation 16.92
|
Adverse Events
Placebo + Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Hydromorphone + Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Dronabinol + Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Hydromorphone + Dronabinol
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo + Placebo
n=58 participants at risk
Placebo + Placebo. 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: Placebo + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Hydromorphone + Placebo
n=58 participants at risk
Hydromorphone + Placebo. 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: Hydromorphone + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Dronabinol + Placebo
n=58 participants at risk
Dronabinol + Placebo. 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: Dronabinol + Placebo. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
Hydromorphone + Dronabinol
n=58 participants at risk
Hydromorphone + Dronabinol. 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: Hydromorphone + Dronabinol. This is a double-blind within-subject Phase II trial. Study medications will remain blinded. All subjects will serve as their own control. Study medication administration will be randomized within each participant.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Chills
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Blood and lymphatic system disorders
Headache
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Cardiac disorders
Hypotensive
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Gastrointestinal disorders
Abdominal Cramps
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Gastrointestinal disorders
Nausea
|
3.4%
2/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
3.4%
2/58 • Up to 40 hours
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Nervous system disorders
Blurred Vision
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
3.4%
2/58 • Up to 40 hours
|
|
Nervous system disorders
Clumsy
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Nervous system disorders
Confusion
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Coughing
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Diaphoresis
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Difficulty Concentrating
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Nervous system disorders
Dizziness
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Nervous system disorders
Drowsiness
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Nervous system disorders
Dry Mouth
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
3.4%
2/58 • Up to 40 hours
|
|
Nervous system disorders
Impaired
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Itchy Eyes
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Light Headed
|
1.7%
1/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
3.4%
2/58 • Up to 40 hours
|
|
Nervous system disorders
Numb
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Nervous system disorders
Restless
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
3.4%
2/58 • Up to 40 hours
|
|
Nervous system disorders
Tremor
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
1.7%
1/58 • Up to 40 hours
|
|
Renal and urinary disorders
Incontenance
|
1.7%
1/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
0.00%
0/58 • Up to 40 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place