Trial Profile
A Multi-Center Extension Study Investigating the Long Term Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Jan 2020
Price :
$35
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At a glance
- Drugs Desmopressin (Primary)
- Indications Nocturia
- Focus Registrational; Therapeutic Use
- Sponsors Ferring Pharmaceuticals
- 21 Jun 2018 According to a Ferring Pharmaceuticals media release, the U.S. FDA granted Ferring Pharmaceuticals Inc. approval to market NOCDURNA, the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The FDA approval of NOCDURNA is based on three double-blind trials (NCT01223937, NCT01262456 and NCT00477490) and one open-label extension trial (NCT00615836, up to three years).
- 14 Dec 2015 End point related to therapeutic effect has been added and time frame has been changed. Design of the trial changed from double-blind to open as reported by ClinicalTrials.gov record.
- 09 Feb 2015 New trial record