Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03751111
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2018-11-21
Brief Title:
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone
Sponsor:
Xiangya Hospital of Central South University
Organization:
Xiangya Hospital of Central South University
Study Overview
Official Title:
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Sublingual Naloxone A Single-blind Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-04
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 purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure
Detailed Description:
This study aims to determine the efficacy and safety of sublingual naloxone in the treatment of chronic refractory itch in patients under long-term arsenic exposure In this study 200 subjects with a moderate-to-severe symptom of itching numeric rating scale NRS3 will be recruited and randomly treated with either sublingual naloxone 100 subjects or placebo 100 subjects The severity of itching will be evaluated in the wash out phase baseline and one week after the treatment through reporting of subjective symptomatology itch NRS via the interview Quality of sleep measured by the Pittsburgh Sleep Quality Index PSQI and Dermatology Life Quality Index DLQI will serve as the secondary outcome
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?:
False
Is an FDA AA801 Violation?:
None