- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024218
Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle
February 22, 2017 updated by: Novo Nordisk A/S
An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle
This trial is conducted in Europe.
The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants.
The trial consists of a handling test followed by a 12 week cross-over study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
København, Denmark, 2400
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks
- Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Device preference
Time Frame: after 12 weeks
|
after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
|
Comparison of the frequency of adverse device effects
|
Comparison of the frequency of adverse events (needle stick injuries)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2004
Primary Completion (Actual)
April 26, 2005
Study Completion (Actual)
April 26, 2005
Study Registration Dates
First Submitted
November 30, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- AUTOCOVER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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