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Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dual-chamber syringe | Other | dual-chamber syringe for mock injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delivery System Success Rate (DSSR) | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All. | Day 1 |
| Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Caverject 10 mcg Device - 5 mcg Dose Setting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delivery System Success Rate (DSSR) | 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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For outcome measure 7, the endpoint was originally the comments provided as part of the PAT. As clinicaltrials.gov do not support textual results, the number of participants who provided comments to any questions on the PAT are reported instead.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all. |
| Day 1 |
| Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | 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. | Day 1 |
| Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult. | Day 1 |
| Number of Participants Providing Responses to Any Question on the PAT | 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? | Day 1 |
| Time Required to Perform Segments 1 to 5 | 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). | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | 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. | Day 1 |
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | 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. | Day 1 |
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | 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. | Day 1 |
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | 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. | Day 1 |
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | 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.
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
| OG008 | 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. |
|
|
| Post-Hoc | DSSR Based on the Primary Objective | 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. | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? | Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All. | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear? | Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all. | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the PAT: Most Difficult Step? | 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. | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult. | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants Providing Responses to Any Question on the PAT | 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? | The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Time Required to Perform Segments 1 to 5 | 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). | 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. | Posted | Mean | Standard Deviation | seconds | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | 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. | 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. | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | 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. | 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. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | 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. | 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. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | 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. | 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. | Posted | Number | participants | Day 1 |
|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | 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. | 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. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | 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. | 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. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | 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. | FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. | Posted | Number | participants | Day 1 |
|
|
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| Secondary | Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | 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. | 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. | Posted | Number | participants | Day 1 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 |
| EG002 | 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. | 0 | 6 | 0 | 6 |
| EG003 | 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. | 0 | 6 | 0 | 6 |
| EG004 | 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. | 0 | 6 | 0 | 6 |
| EG005 | 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. | 0 | 6 | 0 | 6 |
| EG006 | 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. | 0 | 6 | 0 | 6 |
| EG007 | 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. | 0 | 6 | 0 | 6 |
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.
| Somewhat useful |
|
| Not very useful |
|
| Not useful at all |
|
| Missing answer |
|
| Somewhat clear |
|
| Not very clear |
|
| Not clear at all |
|
| Missing answer |
|
| Attaching needle |
|
| Mixing the solution |
|
| Getting the air out of syringe |
|
| Setting the dose |
|
| Pushing plunger |
|
| Other |
|
| Missing answer |
|
| Somewhat easy |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing answer |
|
| Instructions provided were useful? |
|
| Instructions provided were clear? |
|
| Most difficult step? |
|
| Syringe easy to use? |
|
| Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6) |
|
| Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6) |
|
| Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6) |
|
| Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6) |
|
| No (FAIL per OAT) |
|
| No |
|
| Excluded from Q2 |
|
| No (FAIL per OAT) |
|
| Did not participate |
|
| No (FAIL per SAP) |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No (FAIL per OAT) |
|
| Did not participate |
|
| No (FAIL per SAP) |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No (FAIL per OAT) |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No (FAIL per OAT) |
|
| Did not participate |
|
| No (FAIL per OAT) |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| No |
|
| Did not participate |
|
| Not applicable (tested full dose) |
|