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Users Study Of The Caverject Delivery System

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Vince and Associates Clinical Research
Overland Park, Kansas, 66212 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Inability to read English;

- physical limitations preventing participant from operating the syringe

NCT01747928
Pfizer
Completed
Users Study Of The Caverject Delivery System

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Descriptive Information
Brief Title  ICMJE Users Study Of The Caverject Delivery System
Official Title  ICMJE A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System
Brief SummaryUsability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
Detailed DescriptionUsability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Other: dual-chamber syringe
dual-chamber syringe for mock injection
Study Arms  ICMJE Experimental: Group 1
Intervention: Other: dual-chamber syringe
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
Actual Enrollment  ICMJE
 (submitted: May 8, 2013)
48
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2012)
60
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion DateMarch 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Inability to read English;
  • physical limitations preventing participant from operating the syringe
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01747928
Other Study ID Numbers  ICMJE A6711036
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now