A Phase 3 interventional study of Plecanatide in Irritable Bowel Syndrome, sponsored by Bausch Health Americas, Inc.. Completed at 204 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Bausch Health Americas, Inc. · Phase 3, Interventional, and Treatment
Multi-center, open-label, long-term safety study
This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.
Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.
Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.
Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 2,272 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients with documented diagnosis of IBS-C who:
Key Exclusion Criteria:
Plecanatide 6.0 mg tablets
Drug: Plecanatide
Number of Participants With Treatment Related Adverse Events.
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
Time frame: up to 53 weeks
Eligible subjects with IBS-C from SP304203-04 (NCT02387359), SP304203-05 (NCT02493452), and SP304-20212 (NCT01722318), and subjects that did not previously participate in any plecanatide study, were enrolled.
| Milestone | Plecanatide |
|---|---|
| Started | 2272 |
| Completed | 1842 |
| Not completed | 430 |
| Withdrew: Adverse event | 97 |
| Withdrew: Death | 1 |
| Withdrew: Lack of efficacy | 39 |
| Withdrew: Lost to follow-up | 101 |
| Withdrew: Non-compliance with study drug | 15 |
| Withdrew: Physician decision | 6 |
| Withdrew: Pregnancy | 6 |
| Withdrew: Protocol violation | 18 |
| Withdrew: Withdrawal by subject | 136 |
| Withdrew: Non-compliance with visits | 6 |
| Withdrew: Site closure | 4 |
| Withdrew: Subject moved | 1 |
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
| Participants | Plecanatide |
|---|---|
| Number of Participants With Treatment Related Adverse Events. | 205 |
Collected over Up to 53 weeks.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Plecanatide | 1/2,272 (0%) | 45/2,272 (2%) | 341/2,272 (15%) |
| Event | Plecanatide |
|---|---|
| Alanine Aminotransferase IncreasedInvestigations | 6/2272 |
| Aspartate Aminotransferase IncreasedInvestigations | 5/2272 |
| DiverticulitisInfections and infestations | 3/2272 |
| Road Traffic AccidentInjury, poisoning and procedural complications | 2/2272 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 2/2272 |
| Non-Cardiac Chest PainGeneral disorders | 2/2272 |
| Liver Function Test AbnormalInvestigations | 1/2272 |
| Transaminases IncreasedInvestigations | 1/2272 |
| Bacterial PyelonephritisInfections and infestations | 1/2272 |
| CellulitisInfections and infestations | 1/2272 |
| Event | Plecanatide |
|---|---|
| DiarrhoeaGastrointestinal disorders | 153/2272 |
| Upper Respiratory Tract InfectionInfections and infestations | 43/2272 |
| Urinary Tract InfectionInfections and infestations | 34/2272 |
| NasopharyngitisInfections and infestations | 34/2272 |
| NauseaGastrointestinal disorders | 29/2272 |
| HeadacheNervous system disorders | 25/2272 |
| SinusitisInfections and infestations | 23/2272 |
| Age, Continuous(years) | Plecanatide |
|---|---|
| Mean | 45.3 ± 14.18 |
| Sex: Female, Male(Participants) | Plecanatide |
|---|---|
| Female | 1744 |
| Male | 528 |
| Race (NIH/OMB)(Participants) | Plecanatide |
|---|---|
| American Indian or Alaska Native | 4 |
| Asian | 55 |
| Native Hawaiian or Other Pacific Islander | 4 |
| Black or African American | 504 |
| White | 1692 |
| More than one race | 13 |
| Unknown or Not Reported | 0 |
| Body Mass Index(kilograms per meters squared) | Plecanatide |
|---|---|
| Mean | 28.4 ± 4.87 |
Showing the first 100 of 204 sites.
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Bausch Health Americas, Inc.