Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Bausch Health Americas, Inc.2,370 participantsAug 2013 to Mar 2016
Chronic Idiopathic Constipation
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Comparing 2 peptides · Data version 308560
Swipe sideways to see every peptide.
| Peptide | Synthetic analog Plecanatide | Synthetic analog Linaclotide | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Synthetic analog | |
| Area | Gut and digestion | Gut and digestion | |
| Evidence | |||
| Amount of evidence | 178 | 389 | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 54 (54 in people) | 57 (57 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 14 · 1 active | 52 · 7 active8 more mention it but do not test it | |
Shared outcomes
From the regulatory data of each peptide.
The FDA label for Trulance says: “Adults with chronic idiopathic constipation or irritable bowel syndrome with constipation”
Outcome groups with study results for at least two of these peptides. Counts include only results from studies that gave the peptide. Bar length is the number of results, on one scale. The bars show how much was studied, not how large an effect was. A peptide with more studies can look stronger here without being stronger. For results, see the randomized results above.
| Outcome group | Plecanatide | Linaclotide |
|---|---|---|
| Bowel FunctionGastrointestinal | 8080 | 91856 |
| Adverse eventsWhole body |
PepBank is a research reference. Talk to a doctor before you use any peptide.
The FDA label for Linzess says: “IBS-C in adults and pediatric patients aged 7 years and older”
3838
2020 |
| Gastrointestinal adverse eventsGastrointestinal | 1616 | 3636 |
|---|
| PainGastrointestinal | 422 | 4321202 |
|---|
| Gastrointestinal protectionGastrointestinal | 1064 | 362187 |
|---|
| Receptor activity and mechanismGastrointestinal | 541 | 3061014 |
|---|
| Patient-reported outcomesWhole body | 55 | 22 |
|---|
| PharmacokineticsPharmacology | 33 | 7241 |
|---|
| Tumor growthCancer | 22 | 44 |
|---|
| Inflammation markersImmune and inflammation | 11 | 321 |
|---|
Registered trials, ranked by phase (late phases first), then posted results and enrollment. Status is the registry status. Study results come from published studies. Results posted at ClinicalTrials.gov are shown on each trial page.
Top 3 of 14 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Bausch Health Americas, Inc.2,370 participantsAug 2013 to Mar 2016
Chronic Idiopathic Constipation
Bausch Health Americas, Inc.2,272 participantsJan 2016 to Jun 2017
Irritable Bowel Syndrome
Bausch Health Americas, Inc.1,410 participantsApr 2014 to Jul 2015
Chronic Idiopathic Constipation
Top 3 of 52 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Ironwood Pharmaceuticals, Inc.1,743 participantsSept 2008 to Mar 2012
Irritable Bowel Syndrome With Constipation · Chronic Constipation
AstraZeneca1,722 participantsJul 2013 to May 2015
Irritable Bowel Syndrome With Constipation (IBS-C)
Forest Laboratories1,559 participants31 Oct 2008 to 31 Jan 2012
Chronic Constipation · Irritable Bowel Syndrome With Constipation
8 more mention it but do not test it. They only measure it or name it in their text.
For each outcome that two or more peptides have results for: the best result of a single randomized trial, on the same measure (the same kind of number, the same unit). When a trial has several dose arms, the cell shows the highest dose arm. The trials differ in people, length and dose, so a gap between two cells is not proof that one peptide works better.
| Outcome | Plecanatide | Linaclotide |
|---|---|---|
| Bowel FunctionGastrointestinalCompared as: value in the arm that got the peptide, in sbms/week | 3.2 SBMs/week mean weekly SBM frequency increase from baseline · plecanatide 3 mg Placebo: 1.3 SBMs/week Dose studied: 3 mg once daily12 weeksn not reported2017 | 4.02 SBMs/week Change in weekly mean SBM frequency, first week · linaclotide 0.5 mg Placebo: 1.48 SBMs/week Dose studied: 0.5 mgn = 1862019 |
| Gastrointestinal adverse eventsGastrointestinalCompared as: share of people in the arm that got the peptide, in % | 4.9% Diarrhea incidence · plecanatide 3 mg Placebo: 1.3% Dose studied: 3 mg12 weeksn = 1,7622023 | 8.3% Diarrhea incidence |
| Adverse eventsGastrointestinalCompared as: value in the arm that got the peptide, in % | 1.2% discontinuation due to diarrhea · plecanatide 3 mg Placebo: 0% Dose studied: 3 mg12 weeksn not reported2018 | 5.7% Discontinuation due to diarrhea |
3.2 SBMs/week
mean weekly SBM frequency increase from baseline · plecanatide 3 mg
Placebo: 1.3 SBMs/week
Dose studied: 3 mg once daily12 weeksn not reported2017
4.02 SBMs/week
Change in weekly mean SBM frequency, first week · linaclotide 0.5 mg
Placebo: 1.48 SBMs/week
Dose studied: 0.5 mgn = 1862019
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Plecanatide | Linaclotide |
|---|---|---|
| PainGastrointestinalCompared as: difference from placebo, in p-value | No comparable result 2 randomized-trial results measure it in another way or another unit. | 0.1028 p-value P value, abdominal discomfort versus placebo Dose studied: 72 μg once daily12 weeksn not reported2018 |
Placebo: 1.2%
Dose studied: 290 μg/d12 weeksn = 6592022
Placebo: 1.3%
Dose studied: 290 µg once daily8 weeksn = 1672020
4.9%
Diarrhea incidence · plecanatide 3 mg
Placebo: 1.3%
Dose studied: 3 mg12 weeksn = 1,7622023
8.3%
Diarrhea incidence · Linaclotide 290 μg/d
Placebo: 1.2%
Dose studied: 290 μg/d12 weeksn = 6592022
1.2%
discontinuation due to diarrhea · plecanatide 3 mg
Placebo: 0%
Dose studied: 3 mg12 weeksn not reported2018
5.7%
Discontinuation due to diarrhea · linaclotide 290 µg
Placebo: 1.3%
Dose studied: 290 µg once daily8 weeksn = 1672020
| Receptor activity and mechanismGastrointestinalCompared as: value in the arm that got the peptide, in milliseconds | No randomized trial result 5 results from other study designs. | 19 milliseconds P1 latency change from baseline Placebo: 3 milliseconds Dose studied: 290 µg10 weeksn = 392020 |
|---|
| Gastrointestinal protectionGastrointestinalCompared as: value in the arm that got the peptide, in % | No randomized trial result 10 results from other study designs. | 15.7% Primary response · linaclotide 145 μg Placebo: 7.6% Dose studied: 145 μg once daily12 weeksn not reported2015 |
|---|
No comparable result
2 randomized-trial results measure it in another way or another unit.
0.1028 p-value
P value, abdominal discomfort versus placebo
Dose studied: 72 μg once daily12 weeksn not reported2018
No randomized trial result
5 results from other study designs.
19 milliseconds
P1 latency change from baseline
Placebo: 3 milliseconds
Dose studied: 290 µg10 weeksn = 392020
No randomized trial result
10 results from other study designs.
15.7%
Primary response · linaclotide 145 μg
Placebo: 7.6%
Dose studied: 145 μg once daily12 weeksn not reported2015