Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05480761
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2022-06-28
Brief Title:
7-Day Trial of Sucraid for Alleviating CSID Symptoms in Subjects With Low Moderate and Normal Sucrase Levels
Sponsor:
QOL Medical LLC
Organization:
QOL Medical LLC
Study Overview
Official Title:
Evaluation of a 7-Day Therapeutic Trial Dose of Commercial Sucraid Sacrosidase Oral Solution for Alleviating Congenital Sucrase-Isomaltase Deficiency CSID Symptoms in Pediatric Subjects With Low Moderate and Normal Sucrase Levels
Status:
RECRUITING
Status Verified Date:
2023-03
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 Phase 4 US only multi-center study using a 7-day therapeutic response dose TRD of commercial Sucraid to assess the response of treatment in 1100 symptomatic pediatric 6 months to 17 years old subjects with low moderate and normal sucrase activity determined by a disaccharidase assay via EGD within 1 year of the Screening Visit This study will also explore the relationship between known genetic CSID mutations and sucrase activities via EGD disaccharidase assay low moderate and normal
Detailed Description:
This phase 4 study will evaluate the response to Sucraid in pediatric subjects aged 6 months to 17 years old with low 25 µMmingram protein moderate 25-35 µMmingram protein and normal 55 µMmingram protein sucrase activities Subjects with a sucrase level via disaccharidase assay from an EGD within 1 year of informed consentassent a normal histological interpretation and at the discretion of the investigator at least one symptom of carbohydrate maldigestion CMS of postprandial diarrhea abdominal pain gasbloating or defecation urgency at least 3 times per week for the past 3 months or more will be eligible for study participation This study will also explore the relationship between three groups of sucrase levels from the EGD disaccharidase assay and the genetic test This study will consist of a Screening Visit Run-in Period Baseline Visit Treatment Period and Follow-up Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None