Trials / Completed
CompletedNCT00628004
Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers
An Open Label Extension Study (to Study DK143WS) Evaluating the Safety and Long-term Safety Follow-up of Biatain Ibu in Painful Chronic Venous Leg Ulcers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Biatain Ibu | Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked. |
| DEVICE | Local best practice | N/A - since intervention is "local best practice" |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-07-01
- Completion
- 2010-02-01
- First posted
- 2008-03-04
- Last updated
- 2017-04-26
Locations
5 sites across 3 countries: Denmark, Germany, Spain
Source: ClinicalTrials.gov record NCT00628004. Inclusion in this directory is not an endorsement.