Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine
Phase of Trial: Phase III
Latest Information Update: 26 Sep 2017
At a glance
- Drugs Phosphatidylcholine (Primary) ; Mesalazine
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms PROTECT-1
- Sponsors Dr Falk Pharma
- 23 Sep 2017 This trial has been completed in Hungary
- 07 Feb 2017 Status changed from recruiting to discontinued due to IDMC recommendation.
- 09 Dec 2016 This trial was discontinued in Poalnd (end date: 2016-10-13), according to European Clinical Trials Database.