Trial Outcomes & Findings for A Comparison of Proprietary Formulations of Oral Ketamine + Aspirin and Oral Ketamine Alone for Musculoskeletal Pain (NCT NCT04860804)
NCT ID: NCT04860804
Last Updated: 2024-07-17
Results Overview
Change of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
60 minutes
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
AOK Group
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
Aspirin and Ketamine: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
|
OK Group
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine
Oral Ketamine: Proprietary oral formulation of 0.5mg/kg of ketamine
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AOK Group
n=30 Participants
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
Aspirin and Ketamine: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
|
OK Group
n=30 Participants
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine
Oral Ketamine: Proprietary oral formulation of 0.5mg/kg of ketamine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
60 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=30 Participants
|
10 Participants
n=30 Participants
|
24 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
20 Participants
n=30 Participants
|
36 Participants
n=60 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
60 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 60 minutesChange of pain scores on numeric rating pain scale (NRS) at 60 minutes mark form the baseline. The NRS is an 11 item Likert Scale ranging from 0 (no pain) to 10 (very severe pain) with 5 indicating moderate pain.
Outcome measures
| Measure |
AOK Group
n=28 Participants
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
Aspirin and Ketamine: Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
|
OK Group
n=28 Participants
Drug: Proprietary oral formulation of 0.5mg/kg of ketamine
Oral Ketamine: Proprietary oral formulation of 0.5mg/kg of ketamine
|
|---|---|---|
|
Change in Pain Score at 60 Minutes
|
2.18 units on a scale
Standard Deviation 2.1
|
4.01 units on a scale
Standard Deviation 2.1
|
Adverse Events
AOK Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OK Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place