Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161805
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-23
Brief Title:
Esketamine as Treatment for Chronic Pain Due to Endometriosis a RCT Study
Sponsor:
Reinier de Graaf Groep
Organization:
Reinier de Graaf Groep
Study Overview
Official Title:
Esketamine as Treatment for Chronic Pain Due to Endometriosis a RCT Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
EASYlight
Brief Summary:
The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain Secondary endpoints are to assess pain scores side-effects quality of life depressive symptoms and pain coping
Detailed Description:
Endometriosis is a chronic inflammatory disease affecting approximately 10 of reproductive-aged women Severe pain symptoms and subfertility result in a lower quality of life higher prevalence of depression and loss of productivity Consequently the economic impact of endometriosis is high Treatment options to suppress chronic pain symptoms in patients with deep endometriosis are inadequate resulting in increased opioid consumption Ketamine in our study we will use the S-enantiomer esketamine is a versatile drug with analgesic anti-inflammatory and antidepressant effects and is commonly used in the treatment of chronic pain patients and has shown promising outcomes However whilst esketamine targets multiple aspects of endometriosis simultaneously pain inflammation depression studies on esketamine as treatment for chronic pain due to endometriosis have never been reported Therefore we aim to conduct a randomized controlled trial to assess the efficacy of esketamine infusion versus placebo in the treatment of chronic endometriosis-induced pain
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