Trial Profile
A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 22 Jul 2020
Price :
$35
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At a glance
- Drugs Lubiprostone (Primary)
- Indications Constipation
- Focus Registrational; Therapeutic Use
- Sponsors Sucampo Pharmaceuticals
- 05 Jun 2018 Results presented at the Digestive Disease Week 2018
- 30 Apr 2018 According to a Mallinckrodt plc media release, based on data from this trial, the US FDA has approved lubiprostone (AMITIZA) in children 6 to 17 years of age with paediatric functional constipation.
- 09 Nov 2016 Primary endpoint has not been met. (Overall spontaneous bowel movement (SBM) response), according to a Sucampo Pharmaceuticals media release.