2023-508417-16-00RecruitingPhase 4
EASYlight study
Esketamine As treatment for chronic pain due to endometrioSis: a RCT studY
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 24 Oct 2023
- Start date
- 14 Feb 2024
- Lead sponsor
- Reinier de Graaf Groep
- Diseases
- Endometriosis
- EU CT number
- 2023-508417-16-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 56
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women before menopause who have endometriosis with long-lasting pelvic pain. It tests esketamine given by infusion against a saline placebo.
- Age
- 18 to 64 years. The record also says women above 18 years.
- Sex
- Women only.
- Disease stage
- Endometriosis confirmed by ultrasound, MRI or earlier surgery, in the places listed in the Enzian classification. Pelvic pain of 6 or more on a 0 to 10 scale. An indication for endometriosis surgery, or on the waiting list for it.
- Earlier treatment
- Pain not relieved by paracetamol or NSAIDs. No strong opioids, or stopped for more than 1 week. No change in hormone treatment in the last 1 month.
Main reasons for not taking part
- Pain score below 6 out of 10
- Strong opioid use
- Epilepsy, glaucoma or thyroid disease
- Heart failure, unstable angina or earlier stroke
- Past psychiatric illness, alcohol or drug abuse, cancer, or trying to get pregnant or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Usage of strong opioid medication
- Mentally incompetent (patients not able to make decisions that are in their best interests, this will be evaluated by their treating physician (e.g. patients with an intellectual disability or mental retardation))
- -Alcohol or drug abuse
Other illness
- Unstable angina, heart failure, history of cerebral vascular accident (CVA)
- Patients suffering from an active infection
- Patients with epilepsy
- Poorly regulated hypertension, >180/100mmHg at rest
- Patients with thyroid disease
- Patients with cancer
- History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)
- Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)
- Severe liver disease
Lab values
- Endometriosis affecting the bladder and ureter
- -Patient with a known (es)ketamine allergy
- -Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total), defined in protocol V4
Other
- Pain score <6 out of 10 (NRS) for chronic pelvic pain
- Patients with glaucoma
- Usage of xanthine derivatives or ergometrine
- Patients trying to achieve pregnancy and or patients who are breastfeeding
- Not being able to answer questionnaires (in Dutch)
- Increased intracranial pressure
Who the study is looking for
- All pre-menopausal women aged above 18 years
- Women (endometriosis is a condition exclusive to females)
- Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification. This means that endometriosis is present in the following compartments: Rectovaginal space (minimal A1) and/or Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or Rectum (minimal C1) and/or Endometriosis of the intestines, diaphragm and/or Adenomyosis (according to the morphological uterus sonographic assessment (MUSA) or evident adenomyosis on the MRI) and/or Peritoneal / superficial endometriosis (diagnosed laparoscopically and not treated during surgery).
- -Mild to severe chronic pelvic pain (NRS scale >= 6). The 11-point NRS scale ranges from ‘0’ representing no pain to ‘10’ representing the worst pain imaginable.
- -Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)
- -Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week.
- -An indication for endometriosis resection surgery or on the waiting list for surgical treatment
- -Ability to understand the patient information letter and to give oral and written informed consent
- -No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion.
Age in the registry: 18 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reinier de Graaf Groep | Delft | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.