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Novofine Autocover Safety Needle Versus BD Safety Glide

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00121355
Collaborator
(none)
83
Enrollment
1
Location
11
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the NovoFine® Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.

Condition or Disease Intervention/Treatment Phase
  • Device: safety glide
  • Device: autocover needle
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Center, Prospective Cross-Over Study of Preference and Safety of NovoFine® Autocover(TM) Needles Compared to BD Safety Glide (TM) Syringes in the Hospital Setting
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Hospital nurses with prior injection training without an infectious blood borne disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Plainsboro New Jersey United States 08536

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT00121355
    Other Study ID Numbers:
    • MS241-1674
    First Posted:
    Jul 21, 2005
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016

    Study Results

    No Results Posted as of Oct 18, 2016