● Recruiting

Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

Condition: Short Bowel Syndrome · Malabsorption Syndromes · Short Gut Syndrome · Sponsor: Napo Therapeutics, S.p.A.

PhasePhase 2

Planned participants18

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS). Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo.

This description comes directly from the study's public registry record.

Talk to the study team

Sabriye Duran · +49 089 89558070 · sabriye.duran@alirahealth.com

Sara Papetti, MA · +39 3397978779 · spapetti@napo.eu

Always discuss trial participation with your own doctor first.

Locations (8)

Universitäatsklinik RWTH	Aachen, Germany	Recruiting
Charité Universitätsmedizin	Berlin, Germany	Recruiting
Universitätsklinikum	Essen, Germany	Recruiting
Asklepios Klinik St. Georg	Hamburg, Germany	Recruiting
Universitätsmedizin	Rostock, Germany	Recruiting
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi	Bologna, Italy	Recruiting
Azienda Ospedaliera Universitaria Federico II	Naples, Italy	Recruiting
Ospedale Università di Padova	Padova, Italy	Recruiting

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Source record: clinicaltrials.gov/study/NCT06904872