Trial Outcomes & Findings for An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation (NCT NCT03120520)
NCT ID: NCT03120520
Last Updated: 2019-10-04
Results Overview
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.
COMPLETED
PHASE2
124 participants
8 weeks
2019-10-04
Participant Flow
Participant milestones
| Measure |
Matching Placebo
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
30
|
32
|
|
Overall Study
COMPLETED
|
27
|
27
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
3
|
Reasons for withdrawal
| Measure |
Matching Placebo
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
3
|
2
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Baseline characteristics by cohort
| Measure |
Matching Placebo
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.5 mg
n=32 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 1.61 • n=5 Participants
|
15.1 years
STANDARD_DEVIATION 1.48 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
14.6 years
STANDARD_DEVIATION 1.52 • n=4 Participants
|
14.7 years
STANDARD_DEVIATION 1.62 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
104 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
30 participants
n=5 Participants
|
32 participants
n=4 Participants
|
124 participants
n=21 Participants
|
|
Baseline Stool Consistency
|
2.17 units on a scale
STANDARD_DEVIATION 0.932 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.190 • n=7 Participants
|
2.08 units on a scale
STANDARD_DEVIATION .899 • n=5 Participants
|
2.29 units on a scale
STANDARD_DEVIATION 1.298 • n=4 Participants
|
2.13 units on a scale
STANDARD_DEVIATION 1.140 • n=21 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: All randomized participants
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.
Outcome measures
| Measure |
Plecanatide 1.5 mg
n=32 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Matching Placebo
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Proportion of Overall Responders
|
7 Participants
|
7 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants
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.
Outcome measures
| Measure |
Plecanatide 1.5 mg
n=32 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Matching Placebo
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score
|
1.06 units on a scale
Standard Error 0.191
|
0.98 units on a scale
Standard Error 0.209
|
1.09 units on a scale
Standard Error 0.209
|
1.22 units on a scale
Standard Error 0.205
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants
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
Outcome measures
| Measure |
Plecanatide 1.5 mg
n=32 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Matching Placebo
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)
|
2.05 Weekly SBMs
Standard Error 0.328
|
1.44 Weekly SBMs
Standard Error 0.332
|
1.97 Weekly SBMs
Standard Error 0.339
|
2.06 Weekly SBMs
Standard Error 0.343
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All randomized participants
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.
Outcome measures
| Measure |
Plecanatide 1.5 mg
n=32 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Matching Placebo
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 Participants
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)
|
2.11 Weekly CSBMs
Standard Error 0.340
|
1.30 Weekly CSBMs
Standard Error 0.344
|
1.71 Weekly CSBMs
Standard Error 0.348
|
1.83 Weekly CSBMs
Standard Error 0.354
|
Adverse Events
Matching Placebo
Plecanatide 0.5 mg
Plecanatide 1.0 mg
Plecanatide 1.5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Matching Placebo
n=31 participants at risk
Taken orally once daily in the morning for 8 weeks
Matching placebo
|
Plecanatide 0.5 mg
n=31 participants at risk
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.0 mg
n=30 participants at risk
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
Plecanatide 1.5 mg
n=32 participants at risk
Taken orally once daily in the morning for 8 weeks
Plecanatide
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.2%
1/31 • 8 weeks
|
6.5%
2/31 • 8 weeks
|
6.7%
2/30 • 8 weeks
|
3.1%
1/32 • 8 weeks
|
|
Infections and infestations
Acute Tonsillitis
|
3.2%
1/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Infections and infestations
Bronchitis
|
3.2%
1/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Infections and infestations
Infectious Mononucleosis
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
3.3%
1/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
General disorders
Abdominal Discomfort
|
3.2%
1/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
3.1%
1/32 • 8 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
3.1%
1/32 • 8 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
3.3%
1/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/31 • 8 weeks
|
0.00%
0/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
3.1%
1/32 • 8 weeks
|
|
Metabolism and nutrition disorders
Decreased apetite
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/31 • 8 weeks
|
3.2%
1/31 • 8 weeks
|
0.00%
0/30 • 8 weeks
|
0.00%
0/32 • 8 weeks
|
Additional Information
Clinical Operations Director
Bausch Health Americas, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee Contact Sponsor for details.
- Publication restrictions are in place
Restriction type: OTHER