4-Week, Multi-Center, Randomized, Db-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety & Efficacy of Tenapanor for the T/t of IBS-C in Pts. 6 to < 12 Yrs. Old
Ardelyx
Summary
This is a randomized, double-blind, placebo-controlled dose-ranging study to assess the safety and efficacy of tenapanor for treatment of the IBS-C in pediatric patients 6 to less than 12 year old.
Description
This study consists of 2 week screening period in which subjects who have consented will be evaluated for eligibility per protocol requirements. During this 2 week screening period subjects will be given access to ediary in which they will be required to self report symptoms of IBS-C daily. Information in ediary will also be used to determine eligibility prior to enrollment. During the 4 week RTP (Randomized treatment period), subjects will be randomized in in a ratio of 5:1 to receive tenapanor or matching placebo for 4 weeks. During the RTP, patients will continue recording daily assessment…
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥6 and \<12 years old at the Screening visit (Visit 1) 2. Confirmation of negative pregnancy test and use of appropriate contraceptive (including abstinence) in female subjects that have experienced menarche and are of child-bearing potential. 3. Meet the Modified Diagnostic Rome IV criteria for child/adolescent diagnosis of IBS-C 4. Patient is willing to discontinue any laxatives used in favor of the protocol-permitted rescue medicine (which will only be allowed after 72 hours with no bowel movement) 5. Meet the entry criteria assessed during the 2-week Screening perio…
Interventions
- DrugTenapanor
Tenapanor 5 mg/mL solution
- DrugPlacebo
Matching Placebo solution
Locations (17)
- Applied Research Center of ArkansasLittle Rock, Arkansas
- Connecticut Children's Medical CenterHartford, Connecticut
- Waterway Research & Associates Corp.Miami, Florida
- Valencia Medical and Research CenterMiami, Florida
- Orlando Health, Inc.- APH Center for Digestive Health and NutritionOrlando, Florida
- Florida Pharmaceutical Research and Associates, Inc.South Miami, Florida