Trial Outcomes & Findings for Alvimopan as Rescue in Post op Ileus (NCT NCT02742181)
NCT ID: NCT02742181
Last Updated: 2022-11-18
Results Overview
Date of surgery until discharge
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
up to 30 days
Results posted on
2022-11-18
Participant Flow
Participant milestones
| Measure |
Alvimopan Group
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Alvimopan Group
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Alvimopan as Rescue in Post op Ileus
Baseline characteristics by cohort
| Measure |
Alvimopan Group
n=6 Participants
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 Participants
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysDate of surgery until discharge
Outcome measures
| Measure |
Alvimopan Group
n=6 Participants
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 Participants
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Hospital Length of Stay
|
9 Days
Standard Deviation 4.56
|
8.5 Days
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected
Date ileus identified to time of passing flatus, stool and tolerating diet
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysAll adverse events
Outcome measures
| Measure |
Alvimopan Group
n=6 Participants
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 Participants
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Complications
|
4 Number of AEs
|
6 Number of AEs
|
SECONDARY outcome
Timeframe: 30 daysAny reoperations within 30 days of surgery
Outcome measures
| Measure |
Alvimopan Group
n=6 Participants
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 Participants
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Number of Reoperations
|
0 Number of reoperations
|
0 Number of reoperations
|
SECONDARY outcome
Timeframe: 30 daysAny readmissions within 30 days of surgery
Outcome measures
| Measure |
Alvimopan Group
n=6 Participants
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 Participants
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Number of Readmissions
|
0 Number of readmissions
|
0 Number of readmissions
|
Adverse Events
Alvimopan Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alvimopan Group
n=6 participants at risk
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 participants at risk
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
General disorders
Recurrent ileu
|
16.7%
1/6 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
Other adverse events
| Measure |
Alvimopan Group
n=6 participants at risk
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Alvimopan: Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
|
Control Group
n=8 participants at risk
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Control Group: Standard postoperative care
|
|---|---|---|
|
Gastrointestinal disorders
Bloody NG output
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
General disorders
Thrush
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
General disorders
Exacerbation hypertension
|
0.00%
0/6 • 30 days
|
12.5%
1/8 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Acute Kidney injury
|
16.7%
1/6 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
|
Renal and urinary disorders
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • 30 days
|
0.00%
0/8 • 30 days
|
Additional Information
Sharon Stein
University Hospitals Cleveland Medical Center
Phone: (216)844-2873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place