Trial Profile
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 14 Apr 2021
Price :
$35
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At a glance
- Drugs Lubiprostone (Primary)
- Indications Constipation
- Focus Therapeutic Use
- Sponsors Sucampo AG
- 08 Apr 2021 Results of pooled analysis from (NCT03097861 and NCT03010631) evaluating the bioequivalence, pharmacokinetics (PK), and bioavailability of lubiprostone sprinkles vs lubiprostone capsules, compared with placebo published in the Advances in Therapy
- 28 Sep 2017 Primary endpoint (Equivalence analysis of observed spontaneous bowel movement (SBM) count at Week 1 for lubiprostone sprinkle vs. lubiprostone capsule) has not been met, according to a Sucampo Pharmaceuticals media release.
- 22 Aug 2017 Status changed from recruiting to completed.