Trial Profile
Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 04 Dec 2018
Price :
$35
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At a glance
- Drugs Budesonide (Primary) ; Mesalazine (Primary)
- Indications Microscopic colitis
- Focus Registrational; Therapeutic Use
- Sponsors Dr Falk Pharma
- 06 Sep 2018 Primary endpoint (Clinical remission at week 8 / EOT comparison between Salofalk granules and placebo.) has not been met, according to results published in the Gastroenterology.
- 06 Sep 2018 Primary endpoint (Clinical remission at week 8 / EOT comparison between Budenofalk granules placebo.) has been met, according to results published in the Gastroenterology.
- 06 Sep 2018 Results published in the Gastroenterology