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

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ClinicalTrials.gov Identifier: NCT03045926
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : March 11, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Functional Diarrhea of Unknown Origin Drug: Diosmectite (Smecta®) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The study is interventional Phase 1 without individual benefit.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Study Start Date : August 2016
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Diosmectite (Smecta®)
5 weeks of diosmectite 3g, 3 times daily.
Drug: Diosmectite (Smecta®)



Primary Outcome Measures :
  1. 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. ]

    Baseline blood lead levels (BLL) were defined as the average between the available screening and pre-dose (Day-1) values. Values below the limit of detection (LOD) or below the lower limit of quantification (LLOQ) were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in BLL during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in BLL during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).



Secondary Outcome Measures :
  1. 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. ]

    Baseline blood aluminium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood aluminium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood aluminium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  2. 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. ]

    Baseline blood arsenic concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood arsenic concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood arsenic concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  3. 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. ]

    Baseline blood barium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood barium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood barium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  4. 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. ]

    Baseline blood cadmium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood cadmium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood cadmium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  5. 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. ]

    Baseline blood cobalt concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood cobalt concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood cobalt concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  6. 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. ]

    Baseline blood mercury concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood mercury concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood mercury concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  7. 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. ]

    Baseline blood nickel concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in blood nickel concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.

    The absolute mean change from baseline in blood nickel concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study).


  8. 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. ]

    Baseline urine lead levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine lead levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  9. 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. ]

    Baseline urine aluminium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine aluminium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  10. 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. ]

    Baseline urine arsenic levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine arsenic levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  11. 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. ]

    Baseline urine barium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine barium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  12. 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. ]

    Baseline urine cadmium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine cadmium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  13. 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. ]

    Baseline urine cobalt levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine cobalt levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  14. 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. ]

    Baseline urine mercury levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine mercury levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.


  15. 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. ]

    Baseline urine nickel levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.

    The absolute mean change from baseline in urine nickel levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045926


Locations
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Netherlands
PRA Health Sciences
Groningen, Netherlands, 9728NZ
United Kingdom
MAC Clinical Research Limited
Manchester, United Kingdom, M13 9NQ
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
  Study Documents (Full-Text)

Documents provided by Ipsen:
Study Protocol  [PDF] September 7, 2016
Statistical Analysis Plan  [PDF] June 20, 2017


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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03045926     History of Changes
Other Study ID Numbers: D-FR-00250-108
2016-002111-18 ( EudraCT Number )
First Posted: February 8, 2017    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: April 5, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms