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)

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 27 May 2016

At a glance

  • Drugs Lubiprostone (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Abbott Laboratories; Sucampo Pharmaceuticals
  • Most Recent Events

    • 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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