Chronic Functional Diarrhea of Unknown OriginPhase 1NCT03045926

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

A Phase 1 study testing Diosmectite (Smecta®) in people with Chronic Functional Diarrhea of Unknown Origin, run by Ipsen at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Chronic Functional Diarrhea of Unknown Origin
What is being tested?: Diosmectite (Smecta®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2016to 9 May 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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).

Who cannot join

No history of suspected organic or drug induced cause to chronic diarrhoea.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Netherlands1 site

PRA Health Sciences
Groningen, 9728NZ

Other trials in Netherlands

United Kingdom1 site

MAC Clinical Research Limited
Manchester, M13 9NQ

Other trials in United Kingdom

About this study

Official title: Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea

Conditions: Chronic Functional Diarrhea of Unknown Origin
Being tested: Diosmectite (Smecta®)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diosmectite (Smecta®)Drug

Study groups in NCT03045926
Study group	Role	What they receive
Diosmectite (Smecta®)	Experimental	5 weeks of diosmectite 3g, 3 times daily. Receives: Drug: Diosmectite (Smecta®)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period
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).
Measured: Screening and pre-dose Day -1 up to Day 125.
Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period
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).
Measured: 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
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).
Measured: Screening and pre-dose Day -1 up to Day 125.
Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: Screening and pre-dose Day -1 up to Day 125.
Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period
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.
Measured: Screening and pre-dose Day -1 up to Day 95.
Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period
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.
Measured: 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
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.
Measured: Screening and pre-dose Day -1 up to Day 95.
Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period
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.
Measured: 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
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.
Measured: 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
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.
Measured: Screening and pre-dose Day -1 up to Day 95.
Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period
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.
Measured: 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
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.
Measured: Screening and pre-dose Day -1 up to Day 95.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 20169 May 2017

First posted8 Feb 2017 (estimated)
Study startAug 2016
Primary completion9 May 2017
Study completion9 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Functional Diarrhea of Unknown OriginStudies of the same condition, open and under way.
More trials run by IpsenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: The study is interventional Phase 1 without individual benefit.
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03045926
Sponsor's protocol ID: D-FR-00250-108
Other IDs: 2016-002111-18, 2016
Status last verified: Apr 2019
First submitted: 3 Feb 2017
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Da Silva K, Guilly S, Thirion F, Le Chatelier E, Pons N, Roume H, Quinquis B, Ehrlich SD, Bekkat N, Mathiex-Fortunet H, Sokol H, Dore J. Long-term diosmectite use does not alter the gut microbiota in adults with chronic diarrhea. BMC Microbiol. 2022 Feb 12;22(1):54. doi: 10.1186/s12866-022-02464-7.
PubMed 35151268

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Elemental Impurities Level After Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
ClinicalTrials.gov ID: NCT03045926
Acronym / sponsor ID: D-FR-00250-108
Conditions: Chronic Functional Diarrhea of Unknown Origin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: 9 May 2017 (actual)
Study completion: 9 May 2017 (actual)
First posted: 8 Feb 2017 (estimated)
Results: Posted 11 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study is interventional Phase 1 without individual benefit.

Arm	Type	Receives
Diosmectite (Smecta®)	Experimental	Drug: Diosmectite (Smecta®)5 weeks of diosmectite 3g, 3 times daily.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (1 listed)

No history of suspected organic or drug induced cause to chronic diarrhoea.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diosmectite (Smecta®)	Drug	Diosmectite (Smecta®)

Primary outcome

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).

15 secondary outcomes

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 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 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 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 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 Nickel 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 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 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 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 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 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.

Results and safety

Results posted to the registry on 11 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smecta® Powder	35	35

Primary outcome: 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.. Mean (95% Confidence Interval). Unit: nanograms per millilitre (ng/mL)

Measure	Smecta® Powder n = 35
2 hours post-dose, First Dose Day 1	0.120 (-0.823 to 1.063)
Pre-dose, Second Dose Day 1	0.306 (-0.661 to 1.273)
3 hours post-dose, Second Dose Day 1	0.095 (-0.886 to 1.076)
Pre-dose, Third Dose Day 1	0.359 (-0.576 to 1.294)
3 hours post-dose, Third Dose Day 1	0.308 (-0.507 to 1.123)
6 hours post-dose, Third Dose Day 1	-0.096 (-0.915 to 0.724)
Pre-dose, First Dose Day 2	0.836 (-0.163 to 1.835)
Pre-dose, First Dose Day 8	2.539 (1.702 to 3.375)

Population analysed: The Intention-to-Treat (ITT) population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (TEAEs) were collected from Day 1 up to Day 125 (End of Study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smecta® Powder	0 of 35 (0%)	30 of 35 (85.7%)	0 of 35

Limitations and caveats (from the sponsor): The validity of the analytical methods for vanadium determination in human whole blood and urine was not demonstrated. Therefore, no result for vanadium concentration in the clinical samples is reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35151268Da Silva K, Guilly S, Thirion F, Le Chatelier E, Pons N, Roume H, Quinquis B, Ehrlich SD, Bekkat N, Mathiex-Fortunet H, Sokol H, Dore J. Long-term diosmectite use does not alter the gut microbiota in adults with chronic diarrhea. BMC Microbiol. 2022 Feb 12;22(1):54. doi: 10.1186/s12866-022-02464-7.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ipsen Medical Director study director

Ipsen

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Diosmectite (Smecta®) in people with Chronic Functional Diarrhea of Unknown Origin, run by Ipsen at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.