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Sayana-Uniject Volumetric Delivery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298479
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to determine the volumetric delivery of the Uniject.

Condition Intervention Phase
Volume Delivery. Other: Uniject Early Phase 1

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
nurses
Criteria

Inclusion Criteria:

  • Nurses

Exclusion Criteria:

  • Non-nurses
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01298479     History of Changes
Other Study ID Numbers: A6791034
First Submitted: December 16, 2010
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
Last Verified: February 2011

Keywords provided by Pfizer:
volume delivery