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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014