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
Phase of Trial: Phase III
Latest Information Update: 28 Mar 2018
At a glance
- Drugs Lubiprostone (Primary)
- Indications Constipation
- Focus Registrational; Therapeutic Use
- Sponsors Sucampo Pharmaceuticals
- 09 Nov 2016 Primary endpoint has not been met. (Overall spontaneous bowel movement (SBM) response), according to a Sucampo Pharmaceuticals media release.
- 14 Oct 2016 Status changed from active, no longer recruiting to completed.
- 04 May 2016 According to a Sucampo media release, top-line data from this trial and a new drug application filing are expected in the second half of 2016.