Irritable Bowel Syndrome
Conditions
Brief summary
Multi-center, open-label, long-term safety study
Detailed description
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.
Interventions
DRUGPlecanatide
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients with documented diagnosis of IBS-C who: * Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR * Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate. Key
Exclusion criteria
* Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study. * Female patient of childbearing potential with a positive urine pregnancy test on Day 1. * Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial. * Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study. * In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | up to 53 weeks | Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Plecanatide Plecanatide 6.0 mg tablets
Plecanatide | 2,272 |
| Total | 2,272 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 97 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 39 |
| Overall Study | Lost to Follow-up | 101 |
| Overall Study | Non-compliance with study drug | 15 |
| Overall Study | Non-compliance with visits | 6 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Pregnancy | 6 |
| Overall Study | Protocol Violation | 18 |
| Overall Study | Site closure | 4 |
| Overall Study | Subject moved | 1 |
| Overall Study | Withdrawal by Subject | 136 |
Baseline characteristics
| Characteristic | Plecanatide |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 14.18 |
| Body Mass Index | 28.4 kilograms per meters squared STANDARD_DEVIATION 4.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 55 Participants |
| Race (NIH/OMB) Black or African American | 504 Participants |
| Race (NIH/OMB) More than one race | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1692 Participants |
| Sex: Female, Male Female | 1744 Participants |
| Sex: Female, Male Male | 528 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2,272 |
| other Total, other adverse events | 341 / 2,272 |
| serious Total, serious adverse events | 45 / 2,272 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plecanatide | Number of Participants With Treatment Related Adverse Events. | 205 Participants |