SYF067e1d54ffbf419ba7cb21a505ee900aRegistry ID: 2023-508417-16-00|RecruitingPhase 4
EASYlight study
Esketamine As treatment for chronic pain due to endometrioSis: a RCT studY
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Esketamine As treatment for chronic pain due to endometrioSis: a RCT studY
interventional
N/A
1 country
1
The primary aim of the EASYlight study is to assess the effect of 8 hour esketamine infusion versus placebo (saline) on the numeric rating scale score (NRS score) for chronic pelvic pain in patients with chronic pain associated with endometriosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2023
Actual (reported)NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment
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)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Ondansetron Morningside 4 mg orodispergeerbare tabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORODISPERSIBLE TABLET
View registry recordFormulated product
Ondansetron 2 mg/ml Solution for Injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Ketanest® S 5 mg/ml - Ampullen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Ondansetron Morningside 4 mg orodispergeerbare tabletten
Named ingredient: Ondansetron
View registry recordOndansetron 2 mg/ml Solution for Injection
Named ingredient: Ondansetron
View registry recordKetanest® S 5 mg/ml - Ampullen
Named ingredient: Esketamine hydrochloride
View registry recordReinier de Graaf Groep
Delft, 2625 AD, Netherlands
Maaike de Leeuw
First Submitted
October 24, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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