CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Diosmectite (Smecta®)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03045926
NCT03045926Phase 1Completed
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Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

Ipsen·interventional·Posted Feb 8, 2017·Updated Apr 5, 2019

In Brief

A Phase 1 clinical trial evaluating Diosmectite (Smecta®) for Chronic Functional Diarrhea of Unknown Origin. Completed, enrolled 35 participants across 2 sites in 2 countries.

Detailed Summary

The main purpose of this study is to assess the concentration of elemental impurities in blood and urine after chronic administration of Smecta® in subjects with chronic functional diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote composition will be investigated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Functional Diarrhea of Unknown Origin
CountriesNetherlands, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartAug 1, 2016
Primary CompletionMay 9, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago

Interventions

Diosmectite (Smecta®)drug