Trial Outcomes & Findings for Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) (NCT NCT03088826)

Results Overview

The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

60 minutes

Results posted on

2022-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	MSIR and Acetaminophen Group The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen	Oxycodone and Acetaminophen Group The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MSIR and Acetaminophen Group n=40 Participants The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen	Oxycodone and Acetaminophen Group n=40 Participants The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen	Total n=80 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 13.2 • n=40 Participants	46.3 years STANDARD_DEVIATION 14.6 • n=40 Participants	43.5 years STANDARD_DEVIATION 14.2 • n=80 Participants
Sex: Female, Male Female	12 Participants n=40 Participants	20 Participants n=40 Participants	32 Participants n=80 Participants
Sex: Female, Male Male	28 Participants n=40 Participants	20 Participants n=40 Participants	48 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants

PRIMARY outcome

Timeframe: 60 minutes

The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain.

Outcome measures

Outcome measures
Measure	MSIR and Acetaminophen Group n=40 Participants The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen Morphine Sulfate: 15mg PO morphine sulfate Acetaminophen: 650 mg Acetaminophen	Oxycodone and Acetaminophen Group n=40 Participants The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen Oxycodone: 10mg Oxycodone Acetaminophen: 650 mg Acetaminophen
Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)	3.95 units on a scale Standard Deviation 2.29	3.95 units on a scale Standard Deviation 2.37

Adverse Events

MSIR and Acetaminophen Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxycodone and Acetaminophen 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

Sergey Motov

Maimonides Medical Center

Phone: 718283600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place