Chronic Idiopathic ConstipationNCT03551873
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
An observational study of Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 3 sites in United States.
Trial summary
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- Plecanatide
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jun 2018to 14 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Lactating women with Chronic idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C)
Who may be able to join
- Females ≥ 18 years of age
- Has been breastfeeding or actively pumping for at least 4 weeks
- Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
- Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
- Weaning must not be underway
Who cannot join
- Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
- Has participated in an investigational drug study within the 90 days prior to CRU admission
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Synergy Research Center 002
North Hollywood, California, 91606
Synergy Research Center 001
Raleigh, North Carolina, 27612
Syergy Research Center 003
Tamarac, Florida, 33319
About this study
Official title: A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
Read the detailed description
This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- Plecanatide
- Keywords
- Breast milk, Lactating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlecanatideDrug
Also called TRULANCE®
Subjects will have been breastfeeding or pumping for at least 4 weeks and must have been prescribed and taking TRULANCE® for at least 14 continuous days prior to Baseline. Breast milk for measurement of TRULANCE® (plecanatide) concentrations will be collected at Day 1.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk
Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state
Measured: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Cavg,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Average concentration of TRULANCE (plecanatide) in breast milk at steady state
Measured: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
AUCτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Area under the concentration-time curve during a dosing interval at steady state interval at steady state
Measured: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state
Measured: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start21 Jun 2018
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Idiopathic ConstipationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anhthu Nguyen, Study director, Synergy Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551873
- Sponsor's protocol ID
- SP304-3117-14
- Status last verified
- Nov 2019
- First submitted
- 19 Apr 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE
- ClinicalTrials.gov ID
- NCT03551873
- Acronym / sponsor ID
- SP304-3117-14
- Conditions
- Chronic Idiopathic Constipation
- Keywords
- Breast milk, Lactating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
Detailed description
This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lactating women with Chronic idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C)
Key inclusion criteria (5 listed)
- Females ≥ 18 years of age
- Has been breastfeeding or actively pumping for at least 4 weeks
- Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
- Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
- Weaning must not be underway
Key exclusion criteria (3 listed)
- Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
- Has participated in an investigational drug study within the 90 days prior to CRU admission
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 |
|---|---|---|
| PlecanatideAlso: TRULANCE®Subjects will have been breastfeeding or pumping for at least 4 weeks and must have been prescribed and taking TRULANCE® for at least 14 continuous days prior to Baseline. Breast milk for measurement of TRULANCE® (plecanatide) concentrations will be collected at Day 1. | Drug | – |
Primary outcome
Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk
Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state
Cavg,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Average concentration of TRULANCE (plecanatide) in breast milk at steady state
AUCτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Area under the concentration-time curve during a dosing interval at steady state interval at steady state
Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk
Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)
Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
Related trials for Chronic Idiopathic Constipation
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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.
Anhthu Nguyen study director
Synergy Pharmaceuticals Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 3 sites in United States.
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 5 inclusion and 3 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk (time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2019.