Clinical trial NCT03097861
Conditions: Chronic Idiopathic Constipation
Sponsor: Sucampo Pharma Americas, LLC
Start date: 2017-03-13; Completion date: 2017-08-17
Enrollment: 552 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).

Detailed description:

Arms: arm 1: Lubiprostone 24 mcg capsule twice daily (BID) for 7 days. arm 2: Lubiprostone 24 mcg sprinkle BID for 7 days. arm 3: Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg administered orally BID intervention 2: 24 mcg administered orally BID

Protocol documents:
Prot_SAP_000.pdf: 
 
Official Title: 
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 
NCT Number: NCT03097861 
Document Date: Protocol Version 2: 06-Jan-2017 
 
 
 


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