Trial Outcomes & Findings for A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot (NCT NCT01870999)
NCT ID: NCT01870999
Last Updated: 2014-01-22
Results Overview
Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
7 Months
Results posted on
2014-01-22
Participant Flow
Participant milestones
| Measure |
400 mg Aripiprazole IM Depot
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
11
|
|
Overall Study
Safety Population; Received Study Drug
|
14
|
15
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
7
|
Reasons for withdrawal
| Measure |
400 mg Aripiprazole IM Depot
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
1
|
|
Overall Study
Subject met withdrawal criteria
|
3
|
2
|
0
|
|
Overall Study
Subject withdrawn by Investigator
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Baseline characteristics by cohort
| Measure |
400 mg Aripiprazole IM Depot
n=14 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=16 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=11 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 MonthsPopulation: Participants who received at least one dose of study medication are included in the safety analysis set.
Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=14 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=15 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety
|
11 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
|
316 ng/mL
Standard Deviation 160
|
269 ng/mL
Standard Deviation 128
|
100 ng/mL
Standard Deviation 68.4
|
PRIMARY outcome
Timeframe: 672 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=3 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
|
212 ng/mL
Standard Deviation 113
|
156 ng/mL
Standard Deviation 67.7
|
95.0 ng/mL
Standard Deviation 86.2
|
PRIMARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=7 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
|
163 μg*h/mL
Standard Deviation 88.8
|
140 μg*h/mL
Standard Deviation 58.4
|
54.5 μg*h/mL
Standard Deviation 39.4
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
|
7.1 Day
Interval 3.0 to 11.2
|
6.5 Day
Interval 0.5 to 21.2
|
5.0 Day
Interval 4.0 to 27.9
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=7 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Steady-state Plasma Concentration (Css,Avg)
|
242 ng/mL
Standard Deviation 132
|
208 ng/mL
Standard Deviation 87.0
|
81.1 ng/mL
Standard Deviation 58.7
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=6 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=4 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
|
46.5 Day
Standard Deviation 10.8
|
29.9 Day
Standard Deviation 8.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
|
89.4 ng/mL
Standard Deviation 37.9
|
74.7 ng/mL
Standard Deviation 20.8
|
30.3 ng/mL
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
|
64.1 ng/mL
Standard Deviation 27.0
|
54.1 ng/mL
Standard Deviation 21.1
|
26.2 ng/mL
Standard Deviation 24.7
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
|
47.8 μg*h/mL
Standard Deviation 19.1
|
38.9 μg*h/mL
Standard Deviation 13.2
|
14.7 μg*h/mL
Standard Deviation 9.47
|
SECONDARY outcome
Timeframe: Pre-dose and 1 to 1344 hours post-dose at Month 5Population: Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=10 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=8 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=4 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
|
6.6 Day
Interval 3.0 to 14.0
|
12.5 Day
Interval 0.5 to 22.2
|
5.5 Day
Interval 0.0 to 27.9
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).
The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=13 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=14 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
Week 12
|
0.0 units on a scale
Standard Deviation 20.2
|
1.1 units on a scale
Standard Deviation 12.1
|
-1.3 units on a scale
Standard Deviation 4.8
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
Week 24
|
-0.8 units on a scale
Standard Deviation 20.9
|
-1.6 units on a scale
Standard Deviation 14.1
|
-1.3 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: All randomized participants with data available were included in this analysis population (LOCF).
The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=13 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=14 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
Week 12
|
-1.2 units on a scale
Standard Deviation 6.1
|
1.3 units on a scale
Standard Deviation 4.0
|
-1.0 units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
Week 24
|
-1.6 units on a scale
Standard Deviation 6.1
|
0.4 units on a scale
Standard Deviation 4.5
|
-1.0 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: All randomized participants with data available were included in this analysis population (LOCF).
The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=13 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=14 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
Week 12
|
1.1 units on a scale
Standard Deviation 4.4
|
0.1 units on a scale
Standard Deviation 3.2
|
0.0 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
Week 24
|
0.5 units on a scale
Standard Deviation 4.2
|
-0.1 units on a scale
Standard Deviation 3.7
|
-0.6 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: All randomized participants with data available were included in this analysis population (LOCF).
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=14 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=16 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
Week 12
|
-0.1 units on a scale
Standard Deviation 0.5
|
0.0 units on a scale
Standard Deviation 0.6
|
-0.2 units on a scale
Standard Deviation 0.4
|
|
Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
Week 24
|
-0.1 units on a scale
Standard Deviation 0.5
|
-0.1 units on a scale
Standard Deviation 0.7
|
-0.2 units on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 24Population: All randomized participants with data available at the given time-point were included in this analysis population.
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=13 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=15 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=9 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
Week 12 (n=12, 13, 9)
|
3.3 units on a scale
Standard Deviation 0.9
|
3.6 units on a scale
Standard Deviation 0.8
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
Week 24
|
3.7 units on a scale
Standard Deviation 1.0
|
3.4 units on a scale
Standard Deviation 0.7
|
3.7 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 7 MonthsPopulation: All randomized participants were included in the analysis population.
The number of participants hospitalized for the Adverse Event "Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.
Outcome measures
| Measure |
400 mg Aripiprazole IM Depot
n=14 Participants
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=16 Participants
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=11 Participants
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia"
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
400 mg Aripiprazole IM Depot
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
300 mg Aripiprazole IM Depot
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
200 mg Aripiprazole IM Depot
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
400 mg Aripiprazole IM Depot
n=14 participants at risk
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=15 participants at risk
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 participants at risk
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
General disorders
Chest Pain
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
Other adverse events
| Measure |
400 mg Aripiprazole IM Depot
n=14 participants at risk
400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
300 mg Aripiprazole IM Depot
n=15 participants at risk
300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
200 mg Aripiprazole IM Depot
n=10 participants at risk
200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
13.3%
2/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
13.3%
2/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
General disorders
Cyst
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
General disorders
Fatigue
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
General disorders
Injection site discomfort
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
General disorders
Injection site pain
|
28.6%
4/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
General disorders
Pyrexia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Bed bug infestation
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Infected insect bite
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Influenza
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Infections and infestations
Vaginal infection
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Blood glucose increased
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Cardiac murmur
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
13.3%
2/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Investigations
Glucose urine present
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Akathisia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Dystonia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Headache
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
20.0%
2/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Sedation
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
13.3%
2/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Nervous system disorders
Tremor
|
21.4%
3/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Hallucination, auditory
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Hallucination, visual
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Nightmare
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.1%
1/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
6.7%
1/15
Safety Population included all randomized participants who received study drug.
|
0.00%
0/10
Safety Population included all randomized participants who received study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14
Safety Population included all randomized participants who received study drug.
|
0.00%
0/15
Safety Population included all randomized participants who received study drug.
|
10.0%
1/10
Safety Population included all randomized participants who received study drug.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 800-562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place