Overall Responder 9/12 Weeks
| Group | Value (% of Overall Responder 9/12 weeks) |
|---|---|
| Plecanatide 0.3 mg | 18.6 |
| Plecanatide 1.0 mg | 16.8 |
| Plecanatide 3.0 mg | 19.0 |
| Placebo | 10.7 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
Experimental
plecanatide 0.3 mg
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
Experimental
plecanatide 1.0 mg
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
Experimental
plecanatide 3.0 mg
Subjects receive plecanatide 3.0 mg for 12 consecutive weeks
Placebo comparator
Placebo
Subjects receive placebo for 12 consecutive weeks
Outcomes the sponsor listed as primary.
Overall Responder 9/12 Weeks
Time frame · 12-Week Treatment Period
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Change From Baseline in 12-week CSBM Weekly Frequency Rate
Time frame · 12-Week Treatment Period
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Change From Baseline in 12-week SBM Weekly Frequency Rate
Time frame · 12-Week Treatment Period
The number of Spontaneous Bowl Movements experienced per week.
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
Time frame · 12-Week Treatment Period
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult 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 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
Time frame · 12-Week Treatment Period
The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% of Overall Responder 9/12 weeks) |
|---|---|
| Plecanatide 0.3 mg | 18.6 |
| Plecanatide 1.0 mg | 16.8 |
| Plecanatide 3.0 mg | 19.0 |
| Placebo | 10.7 |
| Group | Value (CSBMs per week) | Spread |
|---|---|---|
| Plecanatide 0.3 mg | 1.60 | 0.159 |
| Plecanatide 1.0 mg | 1.81 | 0.157 |
| Plecanatide 3.0 mg | 2.18 | 0.159 |
| Placebo | 1.09 | 0.162 |
| Group | Value (SBMs per week) | Spread |
|---|---|---|
| Plecanatide 0.3 mg | 2.20 | 0.190 |
| Plecanatide 1.0 mg | 2.38 | 0.188 |
| Plecanatide 3.0 mg | 3.00 | 0.191 |
| Placebo | 1.35 | 0.194 |
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Plecanatide 0.3 mg | 1.28 | 0.090 |
| Plecanatide 1.0 mg | 1.70 | 0.090 |
| Plecanatide 3.0 mg | 1.97 | 0.089 |
| Placebo | 0.87 | 0.091 |
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Plecanatide 0.3 mg | -1.25 | 0.142 |
| Plecanatide 1.0 mg | -1.46 | 0.142 |
| Plecanatide 3.0 mg | -1.73 | 0.143 |
| Placebo | -1.04 | 0.144 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Plecanatide 0.3 mgSubjects received plecanatide 0.3 mg orally for 12 consecutive weeks | – | 1 / 237 | 55 / 237 |
| Plecanatide 1.0 mgSubjects received plecanatide 1.0 mg orally for 12 consecutive weeks | – | 1 / 238 | 79 / 238 |
| Plecanatide 3.0 mgSubjects received plecanatide 3.0 mg orally for 12 consecutive weeks | – | 2 / 237 | 92 / 237 |
| PlaceboSubjects received placebo orally for 12 consecutive weeks | – | 5 / 236 | 45 / 236 |
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