Trial Profile

Multi-center, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the safety and efficacy of lubiprostone in patients with chronic idiopathic constipation (CIC)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 27 May 2016

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At a glance

05 Aug 2011 The review process for the New Drug Application (NDA) in Japan, submitted to the Japanese Pharmaceuticals and Medical Devices Agency in September 2010, is proceeding as expected, according to a Sucampo Pharmaceuticals media release.
05 Aug 2011 Sucampo Pharmaceuticals has filed a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA), based on the results of the two pivotal trial in the USA and Japan.
10 May 2011 Results presented at Digestive Disease Week 2011.

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