Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01024218
Collaborator
(none)
78
1
4.8
16.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
78 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle
Actual Study Start Date
:
Dec 1, 2004
Actual Primary Completion Date
:
Apr 26, 2005
Actual Study Completion Date
:
Apr 26, 2005
Outcome Measures
Primary Outcome Measures
- Device preference [after 12 weeks]
Secondary Outcome Measures
- 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) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | København | Denmark | 2400 |
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:
NCT01024218
Other Study ID Numbers:
- AUTOCOVER
First Posted:
Dec 2, 2009
Last Update Posted:
Feb 24, 2017
Last Verified:
Feb 1, 2017