DuoCort completes enrolment for pivotal phase II-III adrenal insufficiency trial
- Details
- Published on Tuesday, 11 December 2007 09:22
HELSINGBORG, Sweden - DuoCort Pharma AB announced today that targeted
enrolment is complete in the pivotal phase II-III clinical trial
evaluating 5 mg and 20 mg DuoCort™ dual-release hydrocortisone tablets
for the treatment of adrenal insufficiency – the inability of the body
to produce sufficient amounts of the essential hormone cortisol. With a target of 56 patients, the five sites participating in the trial
have now enrolled 59 patients. Given the small patient numbers in this
rare disease, inclusion of identified patients is continuing and will
close at year-end. The trial protocol was reviewed by EMEA, the
European Medicines Agency, in a Protocol Assistance procedure under the
Orphan Drug program and accepted as a pivotal study. DuoCort™ was
designated as an Orphan Drug in the EU in May 2006. Interim data from
the study is expected to be available in Q3 2008.
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