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Esketamine As treatment for chronic pain due to endometrioSis: a RCT studY

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508417-16-00
Acronym
EASYlight-NEK
Enrollment
56
Registered
2024-01-18
Start date
2024-02-14
Completion date
Unknown
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment

Detailed description

Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain), Treatment experience (including side-effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0-10), Depressive symptoms (HADS), Quality of life (EHP-30, EQ-5D-5L), Cost-effectiveness (adjusted iPCQ, adjusted iMCQ), Pain coping and cognition (PCCL)

Interventions

DRUGSODIUM CHLORIDE
DRUGOndansetron Morningside 4 mg orodispergeerbare tabletten
DRUGOndansetron 2 mg/ml Solution for Injection

Sponsors

Reinier de Graaf Groep
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment

Secondary

MeasureTime frame
Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain), Treatment experience (including side-effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0-10), Depressive symptoms (HADS), Quality of life (EHP-30, EQ-5D-5L), Cost-effectiveness (adjusted iPCQ, adjusted iMCQ), Pain coping and cognition (PCCL)

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026