EUCTR2013-000949-39-DEActive, not recruitingNot Applicable
An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)
Smith & Nephew Inc.0 sites440 target enrollmentStarted: September 16, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 440
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- The informed consent document must be read, signed, and dated by the subject or the subject’s legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject’s chart.
- •- Subject was randomized in 802-247-09-032 and received at least one application of test article.
- •- Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 264
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
Exclusion Criteria
- •Subjects who refuse to provide written informed consent for this study will be excluded from this study.
Investigators
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