Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553547
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
4-Week Multi-Center Randomized Db-Blind Placebo-Controlled Dose-Ranging Study for the IBS-C in Pts 6 to 12 Yrs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
4-Week Multi-Center Randomized Db-Blind Placebo-Controlled Dose-Ranging Study to Assess the Safety Efficacy of Tenapanor for the Tt of IBS-C in Pts 6 to 12 Yrs Old
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 51 to receive tenapanor or matching placebo for 4 weeks During the RTP patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored Patients will return for study visit every weeks Visits 3-6 and will undergo safety assessments as per the protocol At the end of this 4 week period subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period
The study plans to enroll up to 6 cohorts of eligible patients sequentially starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks Subsequent cohorts will assess increasing tenapanor doses following a dose escalation order The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol
During the 4 week RTP Randomized treatment period subjects will be randomized in in a ratio of 51 to receive tenapanor or matching placebo for 4 weeks During the RTP patients will continue recording daily assessments in the eDiary system as instructed and compliance with eDiary entries will be monitored Patients will return for study visit every weeks Visits 3-6 and will undergo safety assessments as per the protocol At the end of this 4 week period subjects will complete 2 week treatment free follow-up period and safety assessments per protocol will be conducted at the end of this 2 week period
The study plans to enroll up to 6 cohorts of eligible patients sequentially starting from Cohort 1 with 12 patients randomized in to receive tenapanor 2 mg BID or matching placebo for 4 weeks Subsequent cohorts will assess increasing tenapanor doses following a dose escalation order The study will proceed to the next dosing cohort if the current cohort completes the 4-week RTP and does not meet any of the dose escalation stopping criteria pre-specified in the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None