Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03045926
• Date of registration: 03/02/2017
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
• Scientific title: Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
• Date of first enrolment: August 2016
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03045926
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Netherlands, United Kingdom

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Functional Diarrhea of Unknown Origin

Intervention(s)

Drug: Diosmectite (Smecta®)

Primary Outcome(s)

Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Secondary Outcome(s)

Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 95.]

Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period [Time Frame: Screening and pre-dose Day -1 up to Day 125.]

Secondary ID(s)

D-FR-00250-108

2016-002111-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03045926