Chronic Idiopathic ConstipationPhase 2NCT03120520
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
A Phase 2 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 36 sites in United States.
Trial summary
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- Plecanatide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 36 sitesUnited States
- Study dates
- Jan 2017to 7 Sep 2018
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female adolescents 12 to less than 18 years of age.
- Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
- Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.
- Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.
Who cannot join
- The patient has a mental age <4 years in the investigator's opinion.
- The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
- The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor.
- The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:
- Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.
- Total abstinence from sexual intercourse since the last menses before study drug administration.
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- Intrauterine device.
- Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.
- The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days weeks prior to Screening.
- The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion.
- The patient has a history of an eating disorder.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Synergy Research Site
Bellevue, Nebraska
Synergy Research Site
Cerritos, California
Synergy Research Site
Cincinnati, Ohio
Synergy Research Site
Columbus, Ohio
Synergy Research Site
Corona, California
Synergy Research Site
Corpus Christi, Texas
Synergy Research Site
Crowley, Louisiana
Synergy Research Site
Dayton, Ohio
Synergy Research Site
DeLand, Florida
Synergy Research Site
Doral, Florida
Synergy Research Site
Downey, California
Synergy Research Site
Fayetteville, North Carolina
Synergy Research Site
Foley, Alabama
Synergy Research Site
Gresham, Oregon
Synergy Research Site
Hialeah, Florida
Synergy Research Site
Houston, Texas
Synergy Research Site
Huntington Beach, California
Synergy Research Site
Idaho Falls, Idaho
Synergy Research Site
Jackson, Tennessee
Synergy Research Site
Jonesboro, Arkansas
Synergy Research Site
Kingsport, Tennessee
Synergy Research Site
McAllen, Texas
Synergy Research Site
Memphis, Tennessee
Synergy Research Site
Meridian, Idaho
Synergy Research Site
Miami, Florida
Synergy Research Site
Newport News, Virginia
Synergy Research Site
Nicholasville, Kentucky
Synergy Research Site
Omaha, Nebraska
Synergy Research Site
Orlando, Florida
Synergy Research Site
Sacramento, California
Synergy Research Site
San Antonio, Texas
Synergy Research Site
Snellville, Georgia
Synergy Research Site
Tampa, Florida
Synergy Research Site
Thomaston, Georgia
Synergy Research Site
Ventura, California
Synergy Research Site
Wilmington, Delaware
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.
Read the detailed description
The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo, when administered for 8 weeks in adolescents with chronic idiopathic constipation.
This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- Plecanatide, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlecanatideDrug
Also called Trulance
Matching placeboDrug
Also called No other names
| Study group | Role | What they receive |
|---|---|---|
| Plecanatide 0.5 mg | Experimental | Taken orally once daily in the morning for 8 weeks Receives: Drug: Plecanatide |
| Plecanatide 1.0 mg | Experimental | Taken orally once daily in the morning for 8 weeks Receives: Drug: Plecanatide |
| Plecanatide 1.5 mg | Experimental | Taken orally once daily in the morning for 8 weeks Receives: Drug: Plecanatide |
| Matching placebo | Placebo comparator | Taken orally once daily in the morning for 8 weeks Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Overall Responders
An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had >3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.
Measured: 8 weeks
Secondary outcomes (3)
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score
Stool consistency was assessed via the 7-point (1-7) Bristol Stool Form Scale (BSFS) and recorded in the bowel movement (BM) and Symptom Diaries. Lower numbers represent more formed stools; higher numbers represent less formed stools. The weekly mean BSFS score per patient = (total of all BSFS scores reported for a corresponding Spontaneous Bowel Movement (SBM) per time period)/n, where n = number of SBMs scored during the time period. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS types were 1) separate hard lumps, like nuts (hard to pass); 2) sausage-shaped but lumpy; 3) like a sausage but with cracks on its surface; 4) like a sausage or snake, smooth and soft; 5) soft blobs with clear-cut edges (passed easily); 6) fluffy pieces with ragged edges, a mushy stool; 7) watery, no solid pieces, entirely liquid.
Measured: 8 weeks
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)
The weekly Spontaneous Bowel Movement (SBM) totals were derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. SBM is defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours
Measured: 8 weeks
Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)
The weekly Complete Spontaneous Bowel Movement (CSBM) totals are derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline is the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. CSBM was defined as a spontaneous bowel movement with the sense of complete evacuation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startJan 2017
- Primary completion7 Sep 2018
- Study completion7 Sep 2018
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120520
- Sponsor's protocol ID
- SP304202-13
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2017
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)
- ClinicalTrials.gov ID
- NCT03120520
- Acronym / sponsor ID
- SP304202-13
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 19 Sep 2019
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 study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to < 18 years diagnosed with Chronic Idiopathic Constipation.
Detailed description
The purpose of the study is to evaluate efficacy, safety, and pharmacokinetics (PK) of oral Plecanatide 0.5, 1.0 and 1.5 mg tablets dosed once a day as compared to matching placebo, when administered for 8 weeks in adolescents with chronic idiopathic constipation.
This study will consist of a 4-week screening period, 8 weeks of treatment, and a 2-week follow-up. The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plecanatide 0.5 mg | Experimental | Drug: PlecanatideTaken orally once daily in the morning for 8 weeks |
| Plecanatide 1.0 mg | Experimental | Drug: PlecanatideTaken orally once daily in the morning for 8 weeks |
| Plecanatide 1.5 mg | Experimental | Drug: PlecanatideTaken orally once daily in the morning for 8 weeks |
| Matching placebo | Placebo comparator | Drug: Matching placeboTaken orally once daily in the morning for 8 weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female adolescents 12 to less than 18 years of age.
- Diagnosed with CIC based on the Rome III criteria for child/adolescent functional constipation (Appendix A).
- Patient is able to voluntarily provide written, signed, and dated (personally and via a legally authorized representative [LAR]) assent/informed consent as applicable to participate in the study.
- Subject's parent/LAR demonstrates an understanding, ability, and willingness to fully comply with study procedures (e.g., accept venipuncture, willing and able to swallow tablets, accept urine drug screen for opiates) and restrictions.
Key exclusion criteria (11 listed)
- The patient has a mental age <4 years in the investigator's opinion.
- The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation.
- The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor.
- The patient, if female of childbearing potential (defined as postmenarche), does not agree to practice 1 of the following medically acceptable methods of birth control throughout the study:
- The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days weeks prior to Screening.
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 | Drug | Plecanatide 0.5 mg, Plecanatide 1.0 mg, Plecanatide 1.5 mg |
| Matching placeboAlso: No other names | Drug | Matching placebo |
Primary outcome
Proportion of Overall Responders
Time frame: 8 weeks
An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had >3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.
3 secondary outcomes
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score
Time frame: 8 weeks
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)
Time frame: 8 weeks
Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plecanatide in people with Chronic Idiopathic Constipation, run by Bausch Health Americas, Inc. at 36 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 4 inclusion and 11 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Sep 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?
Proportion of Overall Responders (time frame: 8 weeks). 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 4 Oct 2019.