Esketamine hydrochloride for Endometriosis

Inclusion criteria

• {"criterion_text":"- All pre-menopausal women aged above 18 years"}
• {"criterion_text":"- Women (endometriosis is a condition exclusive to females)"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Resistant to current recommended lines of analgesics (paracetamol, NSAIDs)"}
• {"criterion_text":"- Usage of strong opioids must not have been prescribed or otherwise have been discontinued for more than 1 week."}
• {"criterion_text":"- An indication for endometriosis resection surgery or on the waiting list for surgical treatment"}
• {"criterion_text":"- Ability to understand the patient information letter and to give oral and written informed consent"}
• {"criterion_text":"- No alteration in the utilization of hormonal therapy ≤1 months prior to inclusion."}

Exclusion criteria

• {"criterion_text":"- Pain score <6 out of 10 (NRS) for chronic pelvic pain"}
• {"criterion_text":"- Patients with glaucoma"}
• {"criterion_text":"- Usage of strong opioid medication"}
• {"criterion_text":"- Usage of xanthine derivatives or ergometrine"}
• {"criterion_text":"- Unstable angina, heart failure, history of cerebral vascular accident (CVA)"}
• {"criterion_text":"- Patients suffering from an active infection"}
• {"criterion_text":"- Patients with epilepsy"}
• {"criterion_text":"- Patients trying to achieve pregnancy and or patients who are breastfeeding"}
• {"criterion_text":"- Not being able to answer questionnaires (in Dutch)"}
• {"criterion_text":"- 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))"}
• {"criterion_text":"- Alcohol or drug abuse"}
• {"criterion_text":"- Endometriosis affecting the bladder and ureter"}
• {"criterion_text":"- Patient with a known (es)ketamine allergy"}
• {"criterion_text":"- Abnormal liver enzyme levels at baseline (ASAT, ALAT, GGT, AF, Bilirubin total), defined in protocol V4"}
• {"criterion_text":"- Increased intracranial pressure"}
• {"criterion_text":"- Poorly regulated hypertension, >180/100mmHg at rest"}
• {"criterion_text":"- Patients with thyroid disease"}
• {"criterion_text":"- Patients with cancer"}
• {"criterion_text":"- History of psychiatric illness (schizophrenia, psychosis, delirium, manic depression)"}
• {"criterion_text":"- Serious medical disease (e.g., cardiovascular, renal , pulmonary or liver disease)"}
• {"criterion_text":"- Severe liver disease"}

Primary endpoints

• {"endpoint_text":"- NRS score for chronic pelvic pain 4 weeks after the 8 hour infusion treatment","definition_or_measurement_approach":"Numeric Rating Scale (11-point NRS; 0=no pain to 10=worst imaginable pain) measured 4 weeks after the single 8-hour infusion treatment."}

Secondary endpoints

• {"endpoint_text":"- Pain scores (NRS scores for dysmenorrhea, dyschezia, dysuria, dyspareunia and chronic pelvic pain)","definition_or_measurement_approach":"NRS scores for specified pain types (as listed)."}
• {"endpoint_text":"- Treatment experience (including side-effects) (Bond&Ladder questionnaire, Bowdle questionnaire, treatment experience rating (on a scale of 0-10)","definition_or_measurement_approach":"Patient-reported treatment experience and side-effects using Bond & Ladder questionnaire, Bowdle questionnaire and a 0-10 treatment experience rating."}
• {"endpoint_text":"- Depressive symptoms (HADS)","definition_or_measurement_approach":"Measured using the Hospital Anxiety and Depression Scale (HADS)."}
• {"endpoint_text":"- Quality of life (EHP-30, EQ-5D-5L)","definition_or_measurement_approach":"Measured using EHP-30 and EQ-5D-5L instruments."}
• {"endpoint_text":"- Cost-effectiveness (adjusted iPCQ, adjusted iMCQ)","definition_or_measurement_approach":"Health economic evaluation using adjusted iPCQ and adjusted iMCQ instruments."}
• {"endpoint_text":"- Pain coping and cognition (PCCL)","definition_or_measurement_approach":"Measured using PCCL instrument."}

Netherlands

Latest Decision Or Authorization Date

05-07-2024

Number Of Sites

1

Number Of Participants

56

Primary sponsor

Full Name

Reinier de Graaf Groep

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Eurocept pharmaceuticals (only esketamine)","duties_or_roles":"Monetary support for esketamine","organisation_type":""}
• {"country":"","full_name":"STIMAG grant","duties_or_roles":"Grant funding","organisation_type":""}