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 Teduglutide | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Synthetic analog | |
| Area | Gut and digestion | Gut and digestion | |
| Evidence | |||
| Amount of evidence | 178 | 362 | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 54 (54 in people) | 73 (73 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 14 · 1 active | 46 · 4 active4 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 | Teduglutide |
|---|---|---|
| Adverse eventsWhole body | 3838 | 5050 |
| Gastrointestinal adverse eventsGastrointestinal |
PepBank is a research reference. Talk to a doctor before you use any peptide.
The FDA label for Gattex says: “Adults and pediatric patients 1 year of age and older with short bowel syndrome who depend on parenteral support”
1616
1717 |
| Gastrointestinal protectionGastrointestinal | 1064 | 47641 |
|---|
| PharmacokineticsPharmacology | 33 | 17134 |
|---|
| Receptor activity and mechanismGastrointestinal | 541 | 1212 |
|---|
| Treatment adherence and retentionWhole body | 33 | 11 |
|---|
| Inflammation markersImmune and inflammation | 11 | 918 |
|---|
| Body weightMetabolic and weight | 11 | 514 |
|---|
| Tumor growthCancer | 22 | 11 |
|---|
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.
No outcome has a randomized-trial result on the same measure for two or more of these peptides yet.
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Plecanatide | Teduglutide |
|---|---|---|
| Gastrointestinal adverse eventsGastrointestinalCompared as: value in the arm that got the peptide, in percent | 4.3 percent Treatment-related emergent diarrhea Placebo: 0.6 percent Dose studied: 3 mg12 weeksn = 6482025 | No comparable result 1 randomized-trial result measure it in another way or another unit. |
| Adverse eventsGastrointestinalCompared as: value in the arm that got the peptide, in % | 24.5% TEAE rate Placebo: 22.2% Dose studied: 0.1 to 48.6 mgsingle dosen = 712013 | No comparable result 2 randomized-trial results measure it in another way or another unit. |
4.3 percent
Treatment-related emergent diarrhea
Placebo: 0.6 percent
Dose studied: 3 mg12 weeksn = 6482025
No comparable result
1 randomized-trial result measure it in another way or another unit.
24.5%
TEAE rate
Placebo: 22.2%
Dose studied: 0.1 to 48.6 mgsingle dosen = 712013
No comparable result
2 randomized-trial results measure it in another way or another unit.
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 46 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Shire88 participants21 Sept 2009 to 24 Jan 2013
Short Bowel Syndrome
Shire86 participants25 Nov 2008 to 25 Jan 2011
Short Bowel Syndrome
Shire84 participants25 May 2004 to 6 Jul 2007
Short Bowel Syndrome
4 more mention it but do not test it. They only measure it or name it in their text.