Proportion of Overall Responders
| Group | Value (Participants) |
|---|---|
| Matching Placebo | 7 |
| Plecanatide 0.5 mg | 10 |
| Plecanatide 1.0 mg | 12 |
| Plecanatide 1.5 mg | 7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
NCT03120520Jan 2017 to 7 Sept 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to \< 18 years diagnosed with Chronic Idiopathic Constipation.
Experimental
Plecanatide 0.5 mg
Taken orally once daily in the morning for 8 weeks
Experimental
Plecanatide 1.0 mg
Taken orally once daily in the morning for 8 weeks
Experimental
Plecanatide 1.5 mg
Taken orally once daily in the morning for 8 weeks
Placebo comparator
Matching placebo
Taken orally once daily in the morning for 8 weeks
Outcomes the sponsor listed as primary.
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.
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score
Time frame · 8 weeks
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.
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)
Time frame · 8 weeks
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
Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)
Time frame · 8 weeks
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Matching Placebo | 7 |
| Plecanatide 0.5 mg | 10 |
| Plecanatide 1.0 mg | 12 |
| Plecanatide 1.5 mg | 7 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | 0.98 | 0.209 |
| Plecanatide 0.5 mg | 1.09 | 0.209 |
| Plecanatide 1.0 mg | 1.22 | 0.205 |
| Plecanatide 1.5 mg | 1.06 | 0.191 |
| Group | Value (Weekly SBMs) | Spread |
|---|---|---|
| Matching Placebo | 1.44 | 0.332 |
| Plecanatide 0.5 mg | 1.97 | 0.339 |
| Plecanatide 1.0 mg | 2.06 | 0.343 |
| Plecanatide 1.5 mg | 2.05 | 0.328 |
| Group | Value (Weekly CSBMs) | Spread |
|---|---|---|
| Matching Placebo | 1.30 | 0.344 |
| Plecanatide 0.5 mg | 1.71 | 0.348 |
| Plecanatide 1.0 mg | 1.83 | 0.354 |
| Plecanatide 1.5 mg | 2.11 | 0.340 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Matching PlaceboTaken orally once daily in the morning for 8 weeks Matching placebo | 0 / 31 | 0 / 31 | 4 / 31 |
| Plecanatide 0.5 mgTaken orally once daily in the morning for 8 weeks Plecanatide | 0 / 31 | 0 / 31 | 7 / 31 |
| Plecanatide 1.0 mgTaken orally once daily in the morning for 8 weeks Plecanatide | 0 / 30 | 0 / 30 | 4 / 30 |
| Plecanatide 1.5 mgTaken orally once daily in the morning for 8 weeks Plecanatide | 0 / 32 | 0 / 32 | 3 / 32 |
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