Trial Outcomes & Findings for Alvimopan as a Rescue Treatment of Postoperative Ileus (NCT NCT04405037)

NCT ID: NCT04405037

Last Updated: 2025-08-20

Results Overview

Number of days from postoperative ileus diagnosis until discharge from hospital

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 65 participants
• Primary outcome timeframe: up to 30 days
• Results posted on: 2025-08-20

Participant Flow

Participant milestones

Measure	Alvimopan Group Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Overall Study STARTED	33	32
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Alvimopan Group Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Overall Study Withdrawal by Subject	1	0
Overall Study Screen Failure- Received Alvimopan Preoperatively	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Alvimopan Group n=31 Participants Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 Participants Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.	Total n=63 Participants Total of all reporting groups
Age, Continuous	56 years n=31 Participants	63 years n=32 Participants	61 years n=63 Participants
Sex: Female, Male Female	10 Participants n=31 Participants	12 Participants n=32 Participants	22 Participants n=63 Participants
Sex: Female, Male Male	21 Participants n=31 Participants	20 Participants n=32 Participants	41 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	32 participants n=32 Participants	63 participants n=63 Participants

PRIMARY outcome

Timeframe: up to 30 days

Number of days from postoperative ileus diagnosis until discharge from hospital

Outcome measures

Measure	Alvimopan Group n=31 Participants Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 Participants Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Hospital Length of Stay	5 days Interval 3.5 to 6.5	6 days Interval 5.0 to 8.0

SECONDARY outcome

Timeframe: up to 30 days

Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet

Outcome measures

Measure	Alvimopan Group n=31 Participants Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 Participants Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Time to Return of Bowel Function	1 days Interval 0.0 to 2.0	2 days Interval 1.0 to 3.5

SECONDARY outcome

Timeframe: within 30 days of surgery

Number of participants with re-operations within 30 days of surgery

Outcome measures

Measure	Alvimopan Group n=31 Participants Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 Participants Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Number of Participants With Re-operation	3 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 30 days

Number of participatnts with re-admissions within 30 days of surgery

Outcome measures

Measure	Alvimopan Group n=31 Participants Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 Participants Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Number of Participants With Re-admissions	7 Participants	5 Participants

Adverse Events

Alvimopan Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Alvimopan Group n=31 participants at risk Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery	Control Group n=32 participants at risk Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Infections and infestations Surgical Site Infection	0.00% 0/31 • 30 days following surgery	12.5% 4/32 • Number of events 4 • 30 days following surgery
Renal and urinary disorders urinary retention	16.1% 5/31 • Number of events 5 • 30 days following surgery	18.8% 6/32 • Number of events 6 • 30 days following surgery
General disorders other post-op complication	16.1% 5/31 • Number of events 5 • 30 days following surgery	9.4% 3/32 • Number of events 3 • 30 days following surgery

Additional Information

Dr. Scott Steele

Cleveland Clinic Foundation

Phone: 216-444-4715

Email: steeles3@ccf.org

Results disclosure agreements

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