Trial Outcomes & Findings for Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation (NCT NCT03523520)
NCT ID: NCT03523520
Last Updated: 2024-09-19
Results Overview
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
24 hours
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Methylnaltrexone Oral Tablets
Methylnaltrexone oral tablets (total 450 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet
|
Methylnaltrexone Subcutaneous Injection
Methylnaltrexone 12mg subcutaneous injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution
|
Naloxegol Oral Tablets
Naloxegol oral tablets (total 25 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
5
|
|
Overall Study
COMPLETED
|
4
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Methylnaltrexone Oral Tablets
n=4 Participants
Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet
|
Methylnaltrexone Subcutaneous Injection
n=3 Participants
Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution
|
Naloxegol Oral Tablets
n=5 Participants
Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 28.3 • n=4 Participants
|
55.3 years
STANDARD_DEVIATION 16.5 • n=3 Participants
|
62.8 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 20.4 • n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
5 participants
n=5 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The number of participants who had a successful bowl movement within 24 hours of administration of study drug
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
Outcome measures
| Measure |
Methylnaltrexone Oral Tablets
n=4 Participants
Methylnaltrexone oral tablets (total 450 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet
|
Methylnaltrexone Subcutaneous Injection
n=3 Participants
Methylnaltrexone 12mg subcutaneous injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution
|
Naloxegol Oral Tablets
n=5 Participants
Naloxegol oral tablets (total 25 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
|
|---|---|---|---|
|
Occurrence of Bowl Movement
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 hours after administration of study drugThe secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.
Outcome measures
| Measure |
Methylnaltrexone Oral Tablets
n=4 Participants
Methylnaltrexone oral tablets (total 450 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet
|
Methylnaltrexone Subcutaneous Injection
n=3 Participants
Methylnaltrexone 12mg subcutaneous injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution
|
Naloxegol Oral Tablets
n=5 Participants
Naloxegol oral tablets (total 25 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
|
|---|---|---|---|
|
Time to Bowl Movement Within 24 Hours
|
292.5 minutes
Standard Deviation 385.4
|
256.5 minutes
Standard Deviation 21.9
|
270.2 minutes
Standard Deviation 187.5
|
Adverse Events
Methylnaltrexone Oral Tablets
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Methylnaltrexone Subcutaneous Injection
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naloxegol Oral Tablets
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylnaltrexone Oral Tablets
n=4 participants at risk
Methylnaltrexone oral tablets (total 450 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 150 mg Oral Tablet: Methylnaltrexone Bromide 150 mg Oral Tablet
|
Methylnaltrexone Subcutaneous Injection
n=3 participants at risk
Methylnaltrexone 12mg subcutaneous injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution \[RELISTOR\]\_#1: Methylnaltrexone Bromide 12 MG Subcutaneous Solution
|
Naloxegol Oral Tablets
n=5 participants at risk
Naloxegol oral tablets (total 25 mg)
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
Naloxegol 25 MG Oral Tablet: Naloxegol 25 MG Oral Tablet
|
|---|---|---|---|
|
Social circumstances
Anxiety
|
0.00%
0/4 • 24 hours
|
33.3%
1/3 • Number of events 1 • 24 hours
|
0.00%
0/5 • 24 hours
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • 24 hours
|
66.7%
2/3 • Number of events 2 • 24 hours
|
20.0%
1/5 • Number of events 1 • 24 hours
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1 • 24 hours
|
0.00%
0/3 • 24 hours
|
20.0%
1/5 • Number of events 1 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place