Trial · NCT01919697
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
NCT01919697, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC). Trials, record NCT01919697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01919697
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
- NCT number
- NCT01919697
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,370 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Plecanatide
- First posted
- 2013-08-09
- Last updated
- 2019-07-02
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 72 weeks | All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE. |
| Primary | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | From first dose up to 72 weeks | Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug |
| Primary | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Body Temperature (°C) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | From first dose up to 72 weeks | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). |
| Primary | Summary of ECG Results Shift From Baseline at > Day 364 | From first dose up to 72 weeks | Baseline was defined as the last non-missing value collected prior to first dose of study drug) |
| Primary | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | From first dose up to 72 weeks | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE. |
| Secondary | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | Form first dose up to 72 weeks | Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
| Secondary | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | From first dose up to 72 weeks | Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose up to 72 weeks | The Safety Population consisted of all enrolled patients who had received at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | From first dose up to 72 weeks | The Safety Population consisted of all enrolled patients who had at least one dose of the study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | mmHg | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | beats per minute | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Body Temperature (°C) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | °C | MEAN |
| PRIMARY | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | breaths per minute | MEAN |
| PRIMARY | Summary of ECG Results Shift From Baseline at > Day 364 | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | participants | NUMBER |
| PRIMARY | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | From first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | participants | NUMBER |
| SECONDARY | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | Form first dose up to 72 weeks | This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study. | score on a scale | MEAN |
| SECONDARY | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | From first dose up to 72 weeks | All enrolled patients who had at least one dose of the study drug and had at least one post-baseline Patient Global Assessment (PGA) were included in this population. A total of 2378 patients including the re-enrolled patients who previously participated and completed this open-label study was used for assessments. | score on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | Plecanatide 3 mg | 123 | Participants | ||
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | Plecantide 6 mg | 620 | Participants | ||
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | Plecanatide 3 mg | 14 | Participants | ||
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | Plecantide 6 mg | 111 | Participants | ||
| Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | Plecanatide 3 mg | Systolic Blood Pressure | 121 | Standard Deviation 13.40 | mmHg |
| Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | Plecantide 6 mg | Systolic Blood Pressure | 122.9 | Standard Deviation 14.11 | mmHg |
| Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | Plecanatide 3 mg | Diastolic Blood Pressure | 75.7 | Standard Deviation 9.19 | mmHg |
| Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | Plecantide 6 mg | Diastolic Blood Pressure | 76.5 | Standard Deviation 8.47 | mmHg |
| Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | Plecanatide 3 mg | 71.2 | Standard Deviation 10.03 | beats per minute | |
| Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | Plecantide 6 mg | 71.9 | Standard Deviation 9.30 | beats per minute |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Plecanatide 3 mg | 224 | |
| Overall Study | STARTED | Plecantide 6 mg | 2,146 | |
| Overall Study | COMPLETED | Plecanatide 3 mg | 171 | |
| Overall Study | COMPLETED | Plecantide 6 mg | 1,761 | |
| Overall Study | NOT COMPLETED | Plecanatide 3 mg | 53 | |
| Overall Study | NOT COMPLETED | Plecantide 6 mg | 385 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Plecanatide 3 mg | 19 | 224 | 24 |
| other | Diarrhoea | Gastrointestinal disorders | Plecanatide 6 mg | 150 | 2,146 | 159 |
| other | Urinary tract infection | Infections and infestations | Plecanatide 3 mg | 13 | 224 | 15 |
| other | Urinary tract infection | Infections and infestations | Plecanatide 6 mg | 38 | 2,146 | 40 |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Plecanatide 3 mg | 1 | 224 | 1 |
| serious | Pregnancy | Pregnancy, puerperium and perinatal conditions | Plecanatide 6 mg | 7 | 2,146 | 7 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Plecanatide 3 mg | 1 | 224 | 1 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Plecanatide 6 mg | 1 | 2,146 | 1 |
| serious | Diverticulitis | Infections and infestations | Plecanatide 3 mg | 2 | 224 | 2 |
| serious | Diverticulitis | Infections and infestations | Plecanatide 6 mg | 0 | 2,146 | 0 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Plecanatide 3 mg | 0 | 224 |
| Total, all-cause mortality | Plecanatide 6 mg | 1 | 2,146 |
| Total, other adverse events | Plecanatide 3 mg | 32 | 224 |
| Total, other adverse events | Plecanatide 6 mg | 188 | 2,146 |
| Total, serious adverse events | Plecanatide 3 mg | 8 | 224 |
| Total, serious adverse events | Plecanatide 6 mg | 32 | 2,146 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29343131 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Plecanatide 3 mg vs Plecantide 6 mg: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | Trial comparisons |
| Plecanatide 3 mg vs Plecantide 6 mg: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | Trial comparisons |
| Plecanatide 3 mg vs Plecantide 6 mg: Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | Trial comparisons |
| Plecanatide 3 mg vs Plecanatide 6 mg: deaths from any cause | Trial comparisons |
| Plecanatide 3 mg vs Plecanatide 6 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01919697
GET https://conductscience.org/api/trials/v1/NCT01919697/results?page=2