Ignite Creation Date:
2025-12-18 @ 9:59 AM
Ignite Modification Date:
2025-12-18 @ 9:59 AM
Study NCT ID:
NCT06719622
Status:
None
Last Update Posted:
2024-12-06 00:00:00
First Post:
2024-12-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of Local Budesonide Treatment in Children with Crohn's Disease Located in the Esophagus And/or Stomach And/or Duodenum
Status:
None
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BETHESDa-CD
Brief Summary:
The prospective, randomized, single-blind study. Children with CD who meet the inclusion criteria will be randomly assigned, based on a computer-generated randomization list, to one of two groups. One group will be treated with budesonide and the other with omeprazole. All preparations will be taken orally by children every 12 hours for 8 weeks. The child will swallow the capsule/capsules (with omeprazole) with water or the content of the ampoule/ampoules (budesonide). For 30 minutes after swallowing each dose, the patient will not drink, eat, chew gum or brush their teeth. After 30 minutes, the patient will be asked to rinse their mouth. The expected time from the start of screening to randomization is 2 weeks. Follow-up visits will take place at weeks 4, 8, and 12 of the study. The permitted deviation from the designated checkpoints (including randomization) is +/- 4 days. At the visit after 8 weeks, a control gastroscopy will be performed with collection of samples for histopathological evaluation. The 12-week visit will be a follow-up check
Detailed Description:
None
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?: