Irritable Bowel Syndrome With Constipation (IBS-C)
Conditions
Brief summary
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C.
Detailed description
Open-label long-term safety study of tenapanor in pediatric patients with IBS-C. Eligible patients who complete the parent study will have an option to enroll in this study. Patients from the parent study will continue tenapanor at the same dose assigned in the parent study which can be titrated to either 50 mg BID or 25 mg BID per guidance in protocol after a patient's first week on the assigned dose. Patients will also return for study visits approximately every 6 weeks for safety assessments.
Interventions
DRUGTenapanor
Eligible patients from the parent study will continue tenapanor at the same dose assigned in the parent study. Doses can be titrated to either 50 mg BID or 25 mg BID
Sponsors
Ardelyx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Open label study
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. ≥6 and \<18 years old at enrollment of either parent study 2. Patient completed the parent study immediately with adequate compliance with study procedures in the opinion of the Investigator 3. Females of child-bearing potential must have negative pregnancy test at the last visit of the parent study and confirm the use of appropriate contraception (including abstinence). 4. Subject is ambulatory 5. Written informed consent by parent/guardian/ Legally Authorized Representative (LAR) and a willingness of both subject and parent/guardian/LAR to participate in the study as it is described
Exclusion criteria
1. Patient discontinued prematurely from the parent study. 2. Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy 3. Pregnant or lactating women 4. If, in the opinion of the Investigator, patient is unable or unwilling to fulfill the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measure Assessment (Adverse Event) | 40 weeks | Incidence of AEs, SAEs and drug related adverse events |
| Safety Measure Assessment (ECG) | 40 weeks | Descriptive summaries of ECG parameters (heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, and RR-interval) |
Countries
United States
Contacts
STUDY_DIRECTORJocelyn Tabora
Ardelyx
Outcome results
None listed