Phase 1
N=35
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Chronic Functional Diarrhea of Unknown Origin
Bottom Line
View on ClinicalTrials.gov: NCT03045926 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period — 0.120; 0.306; 0.095; 0.359 nanograms per millilitre (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Diosmectite (Smecta®) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period |
0.120; 0.306; 0.095; 0.359; 0.308; -0.096 | — |
| SECONDARY Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period |
-14.958; -6.225; -13.708; -1.688; -9.392; -14.181 | — |
| SECONDARY Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period |
-0.029; -0.003; -0.067; -0.059; 0.037; 0.034 | — |
| SECONDARY Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period |
0.229; 1.300; 4.229; 0.341; 0.000; 0.371 | — |
| SECONDARY Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period |
0.017; -0.002; 0.020; -0.029; 0.006; -0.003 | — |
| SECONDARY Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period |
0.006; 0.006; -0.019; -0.007; 0.019; 0.019 | — |
| SECONDARY Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period |
-0.017; -0.005; -0.013; 0.013; 0.012; -0.020 | — |
| SECONDARY Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period |
0.000; -0.257; 0.000; 0.132; 0.129; 0.129 | — |
| SECONDARY Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period |
0.040; -0.027; -0.001 | — |
| SECONDARY Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period |
0.700; -1.400; -3.500 | — |
| SECONDARY Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period |
-2.694; -3.886; -2.467 | — |
| SECONDARY Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period |
1.493; -0.188; -0.166 | — |
| SECONDARY Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period |
-0.051; -0.026; 0.000 | — |
| SECONDARY Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period |
0.045; 0.019; 0.115 | — |
| SECONDARY Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period |
-0.049; -0.024; -0.049 | — |
| SECONDARY Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period |
-0.090; 0.080; 0.401 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32 kg/m2 inclusive (minimum body weight of 50 kg at screening).
- Functional chronic diarrhoea defined as loose or watery stools occurring in at least 75% of stools for the last 3 months (with symptom onset at least 6 months before diagnosis).
Exclusion Criteria
- No history of suspected organic or drug induced cause to chronic diarrhoea.
Data sourced from ClinicalTrials.gov (NCT03045926). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.