NCT06161805

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
0mo left

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Mar 2024Jun 2026

First Submitted

Initial submission to the registry

October 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

October 23, 2023

Last Update Submit

April 8, 2025

Conditions

EndometriosisChronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Chronic pelvic pain

    The effect of treatment allocation on the NRS score for chronic pelvic pain. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

    4 weeks after the 8 hour infusion treatment.

Secondary Outcomes (14)

  • Dysmenorrhea

    Baseline and week 4, 8, 12 after the 8 hour infusion treatment

  • Dyschezia

    Baseline and week 4, 8, 12 after the 8 hour infusion treatment

  • Dysuria

    Baseline and week 4, 8, 12 after the 8 hour infusion treatment

  • Dyspareunia

    Baseline and week 4, 8, 12 after the 8 hour infusion treatment

  • Chronic pelvic pain

    Baseline and week 4, 8, 12 after the 8 hour infusion treatment

  • +9 more secondary outcomes

Study Arms (2)

Esketamine

EXPERIMENTAL

Esketamine dosing regimen is set at 0.1 mg/kg/h as starting dosage. Dosage will be gradually increased based on heart rate, oxygen saturation, blood pressure and side effects (e.g. nausea and dissociative effects) during a period of 8 hours to a maximum of 0.5 mg/kg/h (in steps of 0.1-0.3-0.5 mg/kg/hour).

Drug: Esketamine hydrochloride

Placebo

PLACEBO COMPARATOR

8 hours infusion with saline (NaCl 0.9%)

Drug: Placebo

Interventions

Esketamine hydrochlorideDRUG

Esketamine dosing regimen is set at 0.1 mg/kg/h as starting dosage. Dosage will be gradually increased based on heart rate, oxygen saturation, blood pressure and side effects (e.g. nausea and dissociative effects) during a period of 8 hours to a maximum of 0.5 mg/kg/h (in steps of 0.1-0.3-0.5 mg/kg/hour). This dosage regimen is similar to that used earlier by Sigtermans et al. \[1\].

Also known as: ketanest
Esketamine
PlaceboDRUG

8 hour infusion with saline (NaCl 0.9%)

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEndometriosis is a condition exclusive to females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • All pre-menopausal women aged above 18 years
  • Diagnosed with endometriosis (ultrasound, MRI or previous laparoscopic and/or diagnostic surgery) according to the #Enzian classification \[52\]. 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) \[53, 54\] 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

You may not qualify if:

  • Pain score \<6 out of 10 (NRS) for chronic pelvic pain
  • Endometriosis affecting the bladder and ureter
  • Increased intracranial pressure
  • 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
  • Patients with glaucoma
  • Usage of strong opioid medication
  • Usage of xanthine derivatives or ergometrine
  • Unstable angina, heart failure, history of cerebral vascular accident (CVA)
  • Patients suffering from an active infection
  • Patients with epilepsy
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nederlandse Endometriose Kliniek, Reinier de Graaf Gasthuis

Delft, Netherlands

RECRUITING

Related Publications (1)

  • Sigtermans MJ, van Hilten JJ, Bauer MCR, Arbous SM, Marinus J, Sarton EY, Dahan A. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain. 2009 Oct;145(3):304-311. doi: 10.1016/j.pain.2009.06.023. Epub 2009 Jul 14.

    PMID: 19604642BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Mathijs Blikkendaal, MD, PhD

CONTACT

070 340 1222M.Blikkendaal@rdgg.nl

Rozemarijn de Koning, MD

CONTACT

070 340 1222Rozemarijn.deKoning@rdgg.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The researchers and participants will not be informed on the nature of the treatment until the trial is fully completed, and the database is locked. Only the clinical pharmacist who prepares the study medication will be aware of the treatment allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomization
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

December 8, 2023

Study Start

March 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations

NL(1)