Trial Outcomes & Findings for Trial of Alvimopan in Major Spine Surgery (NCT NCT02789111)

NCT ID: NCT02789111

Last Updated: 2020-12-01

Results Overview

time to first bowel movement after surgery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 49 participants
• Primary outcome timeframe: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement
• Results posted on: 2020-12-01

Participant Flow

Forty-nine opioid-naive participants undergoing spine surgery between 2016 and 2018 with neurological monitoring were screened and included for eligibility. A total of 24 patients were assigned to the active group and 25 were assigned to the placebo group. One patient from the alvimopan group had surgery canceled, and thus was excluded from further analysis. In the placebo arm, 4 patients were recruited but withdrew from the study.

All 49 consented participants were assigned to an arm.

Participant milestones

Measure	Alvimopan 12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Alvimopan: Alviimopan 12 mg twice daily up to 15 doses	Placebo Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Placebo: Placebo twice daily up to 15 doses
Overall Study STARTED	24	25
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Alvimopan 12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Alvimopan: Alviimopan 12 mg twice daily up to 15 doses	Placebo Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Placebo: Placebo twice daily up to 15 doses
Overall Study Withdrawal by Subject	1	4

Baseline Characteristics

subjects who withdrew or did not have surgery were not analyzed

Baseline characteristics by cohort

Measure	Alvimopan n=23 Participants 12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Alvimopan: Alviimopan 12 mg twice daily up to 15 doses	Placebo n=20 Participants Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Placebo: Placebo twice daily up to 15 doses	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=23 Participants • subjects who withdrew or did not have surgery were not analyzed	0 Participants n=20 Participants • subjects who withdrew or did not have surgery were not analyzed	0 Participants n=43 Participants • subjects who withdrew or did not have surgery were not analyzed
Age, Categorical Between 18 and 65 years	10 Participants n=23 Participants • subjects who withdrew or did not have surgery were not analyzed	9 Participants n=20 Participants • subjects who withdrew or did not have surgery were not analyzed	19 Participants n=43 Participants • subjects who withdrew or did not have surgery were not analyzed
Age, Categorical >=65 years	13 Participants n=23 Participants • subjects who withdrew or did not have surgery were not analyzed	11 Participants n=20 Participants • subjects who withdrew or did not have surgery were not analyzed	24 Participants n=43 Participants • subjects who withdrew or did not have surgery were not analyzed
Sex: Female, Male Female	14 Participants n=23 Participants • only subjects that completed were analyzed	9 Participants n=20 Participants • only subjects that completed were analyzed	23 Participants n=43 Participants • only subjects that completed were analyzed
Sex: Female, Male Male	9 Participants n=23 Participants • only subjects that completed were analyzed	11 Participants n=20 Participants • only subjects that completed were analyzed	20 Participants n=43 Participants • only subjects that completed were analyzed
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement

time to first bowel movement after surgery

Outcome measures

Measure	Alvimopan n=23 Participants 12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Alvimopan: Alviimopan 12 mg twice daily up to 15 doses	Placebo n=20 Participants Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Placebo: Placebo twice daily up to 15 doses
Time to First Bowel Movement	50 hours Interval 22.0 to 80.0	64 hours Interval 40.0 to 114.0

SECONDARY outcome

Timeframe: time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Population: Placebo vs. Alvimopan

time to resumption oral intake after surgery

Outcome measures

Measure	Alvimopan n=20 Participants 12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Alvimopan: Alviimopan 12 mg twice daily up to 15 doses	Placebo n=23 Participants Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses. Placebo: Placebo twice daily up to 15 doses
Time to Resumption of PO Intake	17 hours Interval 3.0 to 46.0	14.5 hours Interval 3.0 to 25.0

Adverse Events

Alvimopan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Bhiken Naik MD

University of Virginia Department of Aneshtesiology

Phone: 434-924-2283

Email: BIN4N@hscmail.mcc.virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place