At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Safety, Tolerability and Efficacy of Crofelemer Following Multiple Ascending Doses of Crofelemer Powder for Oral Solution in Pediatric Participants With Microvillus Inclusion Disease (MVID)
In Brief
A Phase 3 clinical trial evaluating Crofelemer Powder for Oral Solution and Placebo Powder for Oral Solution for Microvillus Inclusion Disease and 2 related conditions. Active but no longer recruiting, targeting 6 participants across 3 sites in 3 countries.
Detailed Summary
A study that will evaluate the safety, tolerability and preliminary efficacy of multiple ascending doses of crofelemer, compared to placebo, using a randomized cross-over design within each dose level, when administered to participants with MVID receiving parenteral support (PS, defined as TPN with or without supplementary IV fluid requirements). Blinded study drug will be administered as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Assigned study drug will be reconstituted and administered orally (or enterally) three times daily (TID) as a concentrated liquid formulation in each of the three dose levels.
Study Details
Timeline
Interventions
Crofelemer Powder for Oral Solution
Matching Placebo Powder for Oral Solution