Status:
COMPLETED
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
Lead Sponsor:
Coloplast A/S
Conditions:
Leg Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period...
Eligibility Criteria
Inclusion
- The patient has participated in study DK143WS
- The patient is able to understand the treatment and is willing to comply with the treat-ment regimen.
- The patient is willing and able to give written informed consent
Exclusion
- Pregnant or lactating women
- Concomitant participation in other studies
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00628004
Start Date
May 1 2008
End Date
February 1 2010
Last Update
April 26 2017
Active Locations (5)
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1
Aarhus Universitetshospital
Aarhus, Denmark, 8000
2
Bispebjerg Hospital
Copenhagen, Denmark, 2400
3
Odense Universitets Hospital
Odense, Denmark, 5000
4
Georg-August-Universität Göttingen
Göttingen, Germany, 37075