Caverject User Study
Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
1 other identifier
interventional
48
1 country
2
Brief Summary
The purpose of this study is to demonstrate the usability of the system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
March 28, 2012
CompletedApril 6, 2012
April 1, 2012
Same day
November 5, 2009
February 28, 2012
April 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.
Day 1
Secondary Outcomes (6)
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Day 1
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Day 1
- +1 more secondary outcomes
Study Arms (1)
Caverject Impulse
EXPERIMENTALrepresentative users
Interventions
Eligibility Criteria
You may qualify if:
- Age 40 to 70
You may not qualify if:
- Prior syringe skills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 6, 2009
Study Start
February 1, 2011
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 6, 2012
Results First Posted
March 28, 2012
Record last verified: 2012-04