Caverject User Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01008605

First received: November 5, 2009

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2009

Last Updated Date

April 4, 2012

Start Date ^ICMJE

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

usability rating [ Time Frame: 15 min ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01008605 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.

Original Secondary Outcome Measures ^ICMJE

user rating [ Time Frame: 15 min ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Caverject User Study

Official Title ^ICMJE

Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.

Brief Summary

The purpose of this study is to demonstrate the usability of the system.

Detailed Description

demonstrate usability

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Other: delivery system

syringe

Study Arm (s)

Experimental: Caverject Impulse

representative users

Intervention: Other: delivery system

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 40 to 70

Exclusion Criteria:

Prior syringe skills

Gender

Male

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01008605

Other Study ID Numbers ^ICMJE

A6711035

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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