Trial Outcomes & Findings for Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention (NCT NCT03852524)
NCT ID: NCT03852524
Last Updated: 2021-10-27
Results Overview
The time it takes for the participant to have a bowel movement from the end of surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
30 days post-operative
Results posted on
2021-10-27
Participant Flow
Participant milestones
| Measure |
Study Arm: Methylnaltrexone
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
Baseline characteristics by cohort
| Measure |
Study Arm: Methylnaltrexone
n=41 Participants
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 Participants
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Total
n=82 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
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 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
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post-operativeThe time it takes for the participant to have a bowel movement from the end of surgery.
Outcome measures
| Measure |
Study Arm: Methylnaltrexone
n=41 Participants
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 Participants
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Time to First Bowel Movement
|
61.8 hours
Interval 35.7 to 93.6
|
50.7 hours
Interval 17.8 to 110.8
|
SECONDARY outcome
Timeframe: 30 Days post-operativeThe number of hours it takes for the participant to meet all discharge criteria and be released from the hospital.(Time-to-discharge/discharge eligibility)
Outcome measures
| Measure |
Study Arm: Methylnaltrexone
n=41 Participants
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 Participants
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Time to Discharge
|
105.0 Hours
Interval 84.6 to 110.2
|
90.7 Hours
Interval 85.4 to 111.3
|
SECONDARY outcome
Timeframe: 30 Days post-operativeThe time it takes for the participant to discharge
Outcome measures
| Measure |
Study Arm: Methylnaltrexone
n=41 Participants
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 Participants
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Time to Discharge
|
4.29 Days
Interval 3.38 to 8.39
|
4.19 Days
Interval 3.23 to 7.69
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-operativeThe amount of daily narcotics (in morphine milli-equivalents) given to a patient (average of post op day 1 - 3)
Outcome measures
| Measure |
Study Arm: Methylnaltrexone
n=41 Participants
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 Participants
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Daily Narcotics
|
136.8 MME
Interval 107.9 to 168.6
|
148.5 MME
Interval 94.8 to 203.7
|
Adverse Events
Study Arm: Methylnaltrexone
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Arm: Methylnaltrexone
n=41 participants at risk
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 participants at risk
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Psychiatric disorders
Disorientation/ Hallucinations secondary to alcohol withdrawal
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Immune system disorders
Migratory artheralgias/ gout flare up
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
4.9%
2/41 • Number of events 2 • Immediately pre-operative to 30 Days post-operative
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Infections and infestations
Wound Dehiscence
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Vascular disorders
Stroke
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Cardiac disorders
Non-ST-elevation myocardial infarction (NSTEMI)
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Psychiatric disorders
Altered mental status (AMS)
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Blood and lymphatic system disorders
hypoxemia, loss of response
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Social circumstances
Syncope; dehydration; Fracture- Right foot
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Gastrointestinal disorders
Post-Operative Ileus
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Renal and urinary disorders
urinary tract infection (UTI) and hyponatremia
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Cardiac disorders
Atrial fibrillation (also called AFib or AF) with rapid ventricular rate or response (RVR).;
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
Other adverse events
| Measure |
Study Arm: Methylnaltrexone
n=41 participants at risk
The study arm will receive subcutaneous methylnaltrexone (0.15mg/kg rounded to 8 or 12 mg) before surgery and then daily, for the following three days after surgery (four doses).
Methylnaltrexone: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving methylnaltrexone (study drug) will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
Placebo Arm
n=41 participants at risk
The placebo arm will receive subcutaneous placebo before surgery and then daily, for the following three days after surgery (four doses).
Placebo: Randomization of methylnaltrexone to placebo will be at a 1:1 ratio. Those receiving placebo will receive a subcutaneous dose pre-surgery and daily for three days following surgery.
|
|---|---|---|
|
Gastrointestinal disorders
> 3 bowel movements in 1 day
|
9.8%
4/41 • Number of events 4 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Psychiatric disorders
AMS and emesis during attempted bowel movement.
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Infections and infestations
Wound dehiscence / drainage from incision
|
4.9%
2/41 • Number of events 2 • Immediately pre-operative to 30 Days post-operative
|
4.9%
2/41 • Number of events 2 • Immediately pre-operative to 30 Days post-operative
|
|
Blood and lymphatic system disorders
Hemoglobin drop
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Surgical and medical procedures
Intraoperatively, a Cerebrospinal Fluid (CSF) leak was noted.
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Renal and urinary disorders
Diagnosis of Acute Kidney Injury
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Gastrointestinal disorders
Post-operative illeus
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Musculoskeletal and connective tissue disorders
increasing pain with concern for infection without drainage or dis
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
|
Cardiac disorders
Hypotension, syncope
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Renal and urinary disorders
Kidney Disease Improving Global Outcomes Stage III (kidney disease)
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
|
Respiratory, thoracic and mediastinal disorders
left airspace disease concerning for brewing aspiration pneumonia
|
0.00%
0/41 • Immediately pre-operative to 30 Days post-operative
|
2.4%
1/41 • Number of events 1 • Immediately pre-operative to 30 Days post-operative
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place