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NCT00121355 Clinical Trial

Novofine Autocover Safety Needle Versus BD Safety Glide

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00121355
Other study ID # MS241-1674
Secondary ID
Status Completed
Phase Phase 4
First received July 13, 2005
Last updated October 17, 2016
Start date July 2005
Est. completion date June 2006

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hospital nurses with prior injection training without an infectious blood borne disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• safety glide

• autocover needle

Locations
Country Name City State
United States Novo Nordisk Investigational Site Plainsboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

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