Trial Outcomes & Findings for Naloxone SR Capsules in Patients With Opioid Induced Constipation (NCT NCT00984334)
NCT ID: NCT00984334
Last Updated: 2013-12-27
Results Overview
Incidence and severity of treatment emergent adverse events on single dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
3 weeks
Results posted on
2013-12-27
Participant Flow
Participant milestones
| Measure |
Capsules With no Active Drug
Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :
|
Naloxone SR 10mg Capsules
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :
|
Naloxone SR 2.5 mg Capsules
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :
|
Naloxone SR 20 mg Capsules
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :
|
Naloxone SR 5mg Capsules
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
8
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Naloxone SR Capsules in Patients With Opioid Induced Constipation
Baseline characteristics by cohort
| Measure |
Capsules With no Active Drug
n=8 Participants
Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :
|
Naloxone SR 10mg Capsules
n=8 Participants
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :
|
Naloxone SR 2.5 mg Capsules
n=8 Participants
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :
|
Naloxone SR 20 mg Capsules
n=8 Participants
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :
|
Naloxone SR 5mg Capsules
n=8 Participants
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :
|
Total
n=40 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Age Continuous
|
53.3 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
50.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
53.3 years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
8 participants
n=21 Participants
|
26 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
14 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Intent to treat.
Incidence and severity of treatment emergent adverse events on single dosing.
Outcome measures
| Measure |
Capsules With no Active Drug
n=8 Participants
Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :
|
Naloxone SR 10mg Capsules
n=8 Participants
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :
|
Naloxone SR 2.5 mg Capsules
n=8 Participants
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :
|
Naloxone SR 20 mg Capsules
n=8 Participants
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :
|
Naloxone SR 5mg Capsules
n=8 Participants
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :
|
|---|---|---|---|---|---|
|
Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing.
|
8 participants
|
5 participants
|
4 participants
|
6 participants
|
6 participants
|
Adverse Events
Capsules With no Active Drug
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Naloxone SR 10mg Capsules
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Naloxone SR 2.5 mg Capsules
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Naloxone SR 20 mg Capsules
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Naloxone SR 5mg Capsules
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capsules With no Active Drug
n=8 participants at risk
Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :
|
Naloxone SR 10mg Capsules
n=8 participants at risk
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :
|
Naloxone SR 2.5 mg Capsules
n=8 participants at risk
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :
|
Naloxone SR 20 mg Capsules
n=8 participants at risk
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :
|
Naloxone SR 5mg Capsules
n=8 participants at risk
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :
|
|---|---|---|---|---|---|
|
Nervous system disorders
Panic attack
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
Other adverse events
| Measure |
Capsules With no Active Drug
n=8 participants at risk
Placebo capsules once daily for three weeks then twice daily for three weeks.
Placebo :
|
Naloxone SR 10mg Capsules
n=8 participants at risk
Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 10 mg capsules :
|
Naloxone SR 2.5 mg Capsules
n=8 participants at risk
Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 2.5 mg capsules :
|
Naloxone SR 20 mg Capsules
n=8 participants at risk
Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 20mg capsules :
|
Naloxone SR 5mg Capsules
n=8 participants at risk
Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.
Naloxone SR 5 mg capsules :
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
62.5%
5/8 • Number of events 25
|
50.0%
4/8 • Number of events 14
|
25.0%
2/8 • Number of events 3
|
37.5%
3/8 • Number of events 10
|
37.5%
3/8 • Number of events 3
|
|
General disorders
General disorders and administration site conditions
|
37.5%
3/8 • Number of events 3
|
25.0%
2/8 • Number of events 3
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
37.5%
3/8 • Number of events 4
|
|
Nervous system disorders
Nervous system disorders
|
12.5%
1/8 • Number of events 1
|
25.0%
2/8 • Number of events 5
|
25.0%
2/8 • Number of events 2
|
50.0%
4/8 • Number of events 8
|
12.5%
1/8 • Number of events 1
|
Additional Information
Dr C Jordan, Head of Clinical Operations
S.L.A. Pharma UK Ltd
Phone: 44 01923 681001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60