Trial Outcomes & Findings for Naloxegol in Cancer Opioid-Induced Constipation (NCT NCT02745353)
NCT ID: NCT02745353
Last Updated: 2019-12-09
Results Overview
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
4 weeks
Results posted on
2019-12-09
Participant Flow
Participant milestones
| Measure |
A- Naloxegol/ Standard of Care
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
naloxegol
|
B- Standard of Care/ Naloxegol
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
naloxegol
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
4
|
3
|
|
First Intervention (2 Weeks)
COMPLETED
|
1
|
1
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
3
|
2
|
|
Washout (3 Days)
STARTED
|
1
|
1
|
|
Washout (3 Days)
COMPLETED
|
1
|
1
|
|
Washout (3 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
1
|
1
|
|
Second Intervention (2 Weeks)
COMPLETED
|
1
|
0
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naloxegol in Cancer Opioid-Induced Constipation
Baseline characteristics by cohort
| Measure |
A- Naloxegol/Standard of Care
n=4 Participants
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
naloxegol
|
B - Standard of Care/Naloxegol
n=3 Participants
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
naloxegol
|
Total
n=7 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 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
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weekscompletion of treatment defined as participants receiving all single daily doses for 2 weeks
Outcome measures
| Measure |
Arm A (Naloxegol/Standard of Care)
n=4 Participants
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
naloxegol
|
Arm B (Standard of Care/ Naloxego)
n=3 Participants
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
naloxegol
|
|---|---|---|
|
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Naloxegol
|
4 Participants
|
3 Participants
|
|
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Standard of Care
|
1 Participants
|
1 Participants
|
Adverse Events
Naloxegol
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Standard of Care
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naloxegol
n=5 participants at risk
All patients who received a single daily dose of 25 mg Naloxegol during the entire study duration
|
Standard of Care
n=4 participants at risk
All patients who received Standard of Care during the entire study duration
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2 • 1 year
|
0.00%
0/4 • 1 year
|
|
Immune system disorders
Fever
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/4 • 1 year
|
|
Surgical and medical procedures
Hospitalization
|
40.0%
2/5 • Number of events 3 • 1 year
|
25.0%
1/4 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
platelet count decreased
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/4 • 1 year
|
Other adverse events
| Measure |
Naloxegol
n=5 participants at risk
All patients who received a single daily dose of 25 mg Naloxegol during the entire study duration
|
Standard of Care
n=4 participants at risk
All patients who received Standard of Care during the entire study duration
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/4 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 2 • 1 year
|
25.0%
1/4 • Number of events 1 • 1 year
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • 1 year
|
0.00%
0/4 • 1 year
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
0.00%
0/5 • 1 year
|
25.0%
1/4 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place