Trial Outcomes & Findings for Users Study Of The Caverject Delivery System (NCT NCT01747928)
NCT ID: NCT01747928
Last Updated: 2014-05-02
Results Overview
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Day 1
Results posted on
2014-05-02
Participant Flow
A total of 50 participants were screened, among whom 2 did not meet entrance criteria. The remaining 48 participants did and were randomized to study treatment.
Participant milestones
| Measure |
Caverject 10 mcg Device - 2.5 mcg Dose Setting
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 15 mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Users Study Of The Caverject Delivery System
Baseline characteristics by cohort
| Measure |
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
55.3 years
STANDARD_DEVIATION 4.8 • n=10 Participants
|
57.8 years
STANDARD_DEVIATION 6.8 • n=115 Participants
|
51.8 years
STANDARD_DEVIATION 5.6 • n=6 Participants
|
54.8 years
STANDARD_DEVIATION 7.9 • n=6 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
48 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Delivery System Success Rate (DSSR)
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
66.67 percentage of participants
Confidence interval (CI) only calculated for all combined participants.
|
66.67 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
83.33 percentage of participants
CI only calculated for all combined participants.
|
89.58 percentage of participants
Interval 79.34 to 100.0
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Very useful
|
5 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
5 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Somewhat useful
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Not very useful
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Not useful at all
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Missing answer
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Very clear
|
5 participants
|
5 participants
|
5 participants
|
4 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Somewhat clear
|
1 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Not very clear
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Not clear at all
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Missing answer
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
No steps really difficult
|
5 participants
|
5 participants
|
5 participants
|
3 participants
|
4 participants
|
5 participants
|
6 participants
|
4 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Attaching needle
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Mixing the solution
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Getting the air out of syringe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Setting the dose
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Pushing plunger
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Other
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Missing answer
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Very easy
|
6 participants
|
6 participants
|
4 participants
|
3 participants
|
5 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Somewhat easy
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Somewhat difficult
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Very difficult
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Missing answer
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Providing Responses to Any Question on the PAT
Syringe easy to use?
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
|
Number of Participants Providing Responses to Any Question on the PAT
What step did you stop? Why?
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Providing Responses to Any Question on the PAT
Instructions provided were useful?
|
5 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
|
Number of Participants Providing Responses to Any Question on the PAT
Instructions provided were clear?
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
|
Number of Participants Providing Responses to Any Question on the PAT
Most difficult step?
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.
Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time Required to Perform Segments 1 to 5
Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6)
|
142.3 seconds
Standard Deviation 105.78
|
144.5 seconds
Standard Deviation 23.35
|
148.8 seconds
Standard Deviation 37.20
|
189.3 seconds
Standard Deviation 140.13
|
176.0 seconds
Standard Deviation 72.92
|
194.3 seconds
Standard Deviation 107.53
|
246.5 seconds
Standard Deviation 131.85
|
168.2 seconds
Standard Deviation 82.76
|
—
|
|
Time Required to Perform Segments 1 to 5
Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6)
|
64.2 seconds
Standard Deviation 50.03
|
39.5 seconds
Standard Deviation 13.92
|
47.2 seconds
Standard Deviation 21.53
|
73.0 seconds
Standard Deviation 63.11
|
42.3 seconds
Standard Deviation 14.19
|
53.8 seconds
Standard Deviation 30.73
|
53.8 seconds
Standard Deviation 21.68
|
50.2 seconds
Standard Deviation 35.90
|
—
|
|
Time Required to Perform Segments 1 to 5
Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6)
|
43.2 seconds
Standard Deviation 22.13
|
63.3 seconds
Standard Deviation 24.82
|
49.2 seconds
Standard Deviation 15.69
|
60.2 seconds
Standard Deviation 40.41
|
71.8 seconds
Standard Deviation 22.69
|
79.5 seconds
Standard Deviation 89.17
|
55.8 seconds
Standard Deviation 32.03
|
42.6 seconds
Standard Deviation 5.86
|
—
|
|
Time Required to Perform Segments 1 to 5
Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6)
|
31.7 seconds
Standard Deviation 24.20
|
35.7 seconds
Standard Deviation 16.50
|
34.4 seconds
Standard Deviation 29.55
|
37.4 seconds
Standard Deviation 59.77
|
29.0 seconds
Standard Deviation 23.08
|
30.0 seconds
Standard Deviation 26.71
|
20.0 seconds
Standard Deviation 13.07
|
8.4 seconds
Standard Deviation 6.31
|
—
|
|
Time Required to Perform Segments 1 to 5
Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6)
|
27.3 seconds
Standard Deviation 20.38
|
30.8 seconds
Standard Deviation 17.51
|
30.4 seconds
Standard Deviation 17.04
|
38.8 seconds
Standard Deviation 53.64
|
30.3 seconds
Standard Deviation 17.77
|
19.2 seconds
Standard Deviation 11.96
|
30.8 seconds
Standard Deviation 15.25
|
17.4 seconds
Standard Deviation 13.24
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A "No" answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
Yes
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
No (FAIL per OAT)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.
OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
No
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
Excluded from Q2
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.
OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
Yes
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
No (FAIL per OAT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.
OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
Yes
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
No (FAIL per SAP)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.
OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
No
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.
OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
No (FAIL per OAT)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
No (FAIL per SAP)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
No
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
No (FAIL per OAT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
No
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
No (FAIL per OAT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
No (FAIL per OAT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A "Yes" response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
Yes (FAIL per SAP)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
No
|
6 participants
|
6 participants
|
4 participants
|
4 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
Yes
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
No
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.
OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
Yes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
No
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
6 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as "not applicable" as they tested the full dose.
OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
Yes
|
6 participants
|
0 participants
|
5 participants
|
5 participants
|
6 participants
|
0 participants
|
6 participants
|
5 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
No
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
Did not participate
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
Not applicable (tested full dose)
|
0 participants
|
6 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
0 participants
|
0 participants
|
—
|
POST_HOC outcome
Timeframe: Day 1Population: The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.
This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a "failure" only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.
Outcome measures
| Measure |
Caverject 20 mcg Device - 15 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 20 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 2.5 mcg Dose Setting
n=6 Participants
Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 7.5 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 10 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 5 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
Caverject 20 mcg Device - 10 mcg Dose Setting
n=6 Participants
Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
|
All Participants
n=48 Participants
All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
|
|---|---|---|---|---|---|---|---|---|---|
|
DSSR Based on the Primary Objective
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
83.33 percentage of participants
CI only calculated for all combined participants.
|
83.33 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
100.00 percentage of participants
CI only calculated for all combined participants.
|
83.33 percentage of participants
CI only calculated for all combined participants.
|
93.75 percentage of participants
Interval 84.63 to 100.0
|
Adverse Events
Caverject 10 mcg Device - 2.5 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 10 mcg Device - 5 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 10 mcg Device - 7.5 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 10 mcg Device - 10 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 20 mcg Device - 5 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 20 mcg Device - 10 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 20 mcg Device - 15 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caverject 20 mcg Device - 20 mcg Dose Setting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER