Trial Outcomes & Findings for The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus (NCT NCT03176316)

NCT ID: NCT03176316

Last Updated: 2024-07-01

Results Overview

We will monitor the patients' bowel movements and record the time to the first bowel movement in hours

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

1 week

Results posted on

2024-07-01

Participant Flow

Recruitment began on September 20, 2017 and ended on February 20, 2020 when the Institutional Review Board placed the project on administrative hold. Recruitment occurred at a Loyola University Medical Center clinic.

Participant milestones

Participant milestones
Measure	Naloxone Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids). The study administers 1 mg/ml oral solution enterally every eight hours for 48 hours.
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Information on participant age was only collected for 23 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naloxone n=53 Participants Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids). The study administers 1 mg/ml oral solution enterally every eight hours for 48 hours.
Age, Continuous	65.91 years STANDARD_DEVIATION 9.99 • n=23 Participants • Information on participant age was only collected for 23 participants.
Sex: Female, Male Female	25 Participants n=53 Participants
Sex: Female, Male Male	28 Participants n=53 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=53 Participants
Race (NIH/OMB) Asian	1 Participants n=53 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=53 Participants
Race (NIH/OMB) Black or African American	2 Participants n=53 Participants
Race (NIH/OMB) White	19 Participants n=53 Participants
Race (NIH/OMB) More than one race	0 Participants n=53 Participants
Race (NIH/OMB) Unknown or Not Reported	31 Participants n=53 Participants
Region of Enrollment United States	53 Participants n=53 Participants

PRIMARY outcome

Timeframe: 1 week

Population: The research team collected outcome data on one participant. The Institutional Review Board terminated the study early due to non-compliance with continuing review requirements.

We will monitor the patients' bowel movements and record the time to the first bowel movement in hours

Outcome measures

Outcome measures
Measure	Naloxone n=1 Participants Naloxone is an opioid antagonist (i.e., a medication used to reverse or reduce the effects of opioids). The study administers 1 mg/ml oral solution enterally every eight hours for 48 hours.
Time to First Bowel Movement	43.62 Hours

Adverse Events

Naloxone

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

Russell Nockels, M.D.

Loyola University Medical Center

Phone: 847-618-9565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place