A Phase 2 interventional study of Plecanatide and Matching placebo in Chronic Idiopathic Constipation, sponsored by Bausch Health Americas, Inc.. Completed at 36 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by Bausch Health Americas, Inc. · Phase 2, Interventional, and Treatment
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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:
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Taken orally once daily in the morning for 8 weeks
Drug: Plecanatide
Taken orally once daily in the morning for 8 weeks
Drug: Matching placebo
Also known as: Trulance
Also known as: No other names
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.
Time frame: 8 weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 8 weeks
| Milestone | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| Started | 31 | 31 | 30 | 32 |
| Completed | 27 | 27 | 26 | 29 |
| Not completed | 4 | 4 | 4 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 2 | 3 | 2 |
| Withdrew: Other | 0 | 1 | 0 | 0 |
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.
| Participants | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| Proportion of Overall Responders | 7 | 10 | 12 | 7 |
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.
| units on a scale | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score | 0.98 ± 0.209 | 1.09 ± 0.209 | 1.22 ± 0.205 | 1.06 ± 0.191 |
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
| Weekly SBMs | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM) | 1.44 ± 0.332 | 1.97 ± 0.339 | 2.06 ± 0.343 | 2.05 ± 0.328 |
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.
| Weekly CSBMs | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM) | 1.30 ± 0.344 | 1.71 ± 0.348 | 1.83 ± 0.354 | 2.11 ± 0.340 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Matching Placebo | 0/31 (0%) | 0/31 (0%) | 4/31 (12.9%) |
| Plecanatide 0.5 mg | 0/31 (0%) | 0/31 (0%) | 7/31 (22.6%) |
| Plecanatide 1.0 mg | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Plecanatide 1.5 mg | 0/32 (0%) | 0/32 (0%) | 3/32 (9.4%) |
| Event | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/31 | 2/31 | 2/30 | 1/32 |
| Viral upper respiratory tract infectionInfections and infestations | 0/31 | 0/31 | 1/30 | 0/32 |
| NeutropeniaBlood and lymphatic system disorders | 0/31 | 0/31 | 1/30 | 0/32 |
| Acute TonsillitisInfections and infestations | 1/31 | 0/31 | 0/30 | 0/32 |
| BronchitisInfections and infestations | 1/31 | 0/31 | 0/30 | 0/32 |
| Infectious MononucleosisInfections and infestations | 0/31 | 1/31 | 0/30 | 0/32 |
| Pharyngitis streptococcalInfections and infestations | 0/31 | 1/31 | 0/30 | 0/32 |
| Upper respiratory tract infectionInfections and infestations | 0/31 | 1/31 | 0/30 | 0/32 |
| Abdominal DiscomfortGeneral disorders | 1/31 | 0/31 | 0/30 | 0/32 |
| Gilbert's syndromeCongenital, familial and genetic disorders | 0/31 | 1/31 | 0/30 | 0/32 |
| Age, Continuous(years) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| Mean | 14.6 ± 1.61 | 15.1 ± 1.48 | 14.5 ± 1.89 | 14.6 ± 1.52 | 14.7 ± 1.62 |
| Sex: Female, Male(Participants) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| Female | 17 | 17 | 17 | 18 | 69 |
| Male | 14 | 14 | 13 | 14 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 21 | 21 | 23 | 27 | 92 |
| Not Hispanic or Latino | 10 | 10 | 7 | 5 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 3 | 2 | 16 |
| White | 24 | 24 | 27 | 29 | 104 |
| More than one race | 1 | 1 | 0 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| United States | 31 | 31 | 30 | 32 | 124 |
| Baseline Stool Consistency(units on a scale) | Matching Placebo | Plecanatide 0.5 mg | Plecanatide 1.0 mg | Plecanatide 1.5 mg | Total |
|---|---|---|---|---|---|
| Mean | 2.17 ± 0.932 | 2.0 ± 1.190 | 2.08 ± .899 | 2.29 ± 1.298 | 2.13 ± 1.140 |
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Bausch Health Americas, Inc.