Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07168720
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Sponsor:
Guangzhou Novaken Pharm Co., Ltd.
Organization:
Study Overview
Official Title:
Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children
Status:
RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
Detailed Description:
A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: