Users Study Of The Caverject Delivery System

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: November 20, 2012
Last updated: May 8, 2013
Last verified: May 2013

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

Condition Intervention Phase
Other: dual-chamber syringe
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Successful performance of the mock injection according to the Instructions for Use (IFU) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: March 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Other: dual-chamber syringe
dual-chamber syringe for mock injection

Detailed Description:

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


Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Inability to read English;
  • physical limitations preventing participant from operating the syringe
  Contacts and Locations
Please refer to this study by its identifier: NCT01747928

United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01747928     History of Changes
Other Study ID Numbers: A6711036
Study First Received: November 20, 2012
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
usability study

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 16, 2014