Sayana-Uniject Volumetric Delivery

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01298479
First received: December 16, 2010
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to determine the volumetric delivery of the Uniject.


Condition Intervention Phase
Volume Delivery.
Other: Uniject
Phase 0

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quantitative Determination of the Volume of Suspension Delivered Via the Uniject Delivery System Following Simulated Subcutaneous Injection by Healthcare Professionals Into a Synthetic Subcutaneous Injection Training Device

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Weight of drug suspension delivered (estimated by change in mass of the Uniject(TM) delivery system). [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
All subjects
Other: Uniject
single use container

Detailed Description:

Observe subjects deliver the drug None used

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

nurses

Criteria

Inclusion Criteria:

  • Nurses

Exclusion Criteria:

  • Non-nurses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298479

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01298479     History of Changes
Other Study ID Numbers: A6791034
Study First Received: December 16, 2010
Last Updated: February 16, 2011
Health Authority: Belgium: Federal Agenecy for Medicines and Health Products.

Keywords provided by Pfizer:
volume delivery

ClinicalTrials.gov processed this record on April 17, 2014