Clinical trial NCT01747928: Users Study Of The Caverject Delivery System
Official title: A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: usability study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-12
Enrollment: 48
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.

Detailed description: Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use

Eligibility criteria: Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Inability to read English;
* physical limitations preventing participant from operating the syringe

Primary outcomes:
measure: Delivery System Success Rate (DSSR)
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
timeFrame: Day 1
measure: Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
timeFrame: Day 1
measure: Number of Participants Providing Responses to Any Question on the PAT
timeFrame: Day 1
measure: Time Required to Perform Segments 1 to 5
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
timeFrame: Day 1
measure: Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
timeFrame: Day 1
measure: Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
timeFrame: Day 1
measure: Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
timeFrame: Day 1
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: