Text Size

Users Study Of The Caverject Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01747928
First received: November 20, 2012
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 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:

Drug Information available for: Alprostadil
U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01747928

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov 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:
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
 Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013