38
Participants
Start Date
January 20, 2014
Primary Completion Date
July 16, 2014
Study Completion Date
July 16, 2014
FE 992097
"Each spray pump actuation delivered a 50 μL volume of solution that contained 1.6 mg carbetocin (FE 992097); each dose consisted of 3 spray pump actuations in each nostril that delivered a total of 9.6 mg carbetocin.~Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days."
Placebo
"Each spray pump actuation delivered a 50 μL volume of sterile sodium chloride solution 0.9%; each dose consisted of 3 spray pump actuations in each nostril.~Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days."
Florida University, Gainesville
Winthrop University, Mineola
Vanderbilt University, Nashville
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY