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Study on Esketamine for Treating Chronic Pain in Endometriosis Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for chronic pain associated with endometriosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, often causing pain. The treatment being tested is an infusion of esketamine hydrochloride, which is a medication that can act as an anesthetic and has potential antidepressant effects. The study will compare the effects of esketamine with a placebo, which is a substance with no active medication, to see how it affects pain levels in patients.

The main goal of the study is to assess how an 8-hour infusion of esketamine affects the pain experienced by patients with endometriosis. Participants will receive either the esketamine infusion or a placebo. The study will measure pain levels using a numeric rating scale, where patients rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable). This will help determine if esketamine can effectively reduce chronic pelvic pain in these patients.

Throughout the study, participants will be monitored for any changes in their pain levels and overall treatment experience, including any side effects. The study will also look at other factors such as quality of life and any depressive symptoms. The results will help understand the potential benefits and risks of using esketamine for managing chronic pain in endometriosis, providing valuable information for future treatment options.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide written consent to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of endometriosis and assessing your pain levels using a numeric rating scale (NRS) from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Step 3
Treatment phase
During the treatment phase, you will receive an 8-hour infusion. This will either be esketamine hydrochloride or a placebo (saline solution). The infusion is administered intravenously, meaning it is delivered directly into your vein.
Step 4
Medication details
The medication used in the study includes esketamine hydrochloride administered intravenously. You may also receive ondansetron to help manage any potential side effects. Ondansetron can be given as an orodispersible tablet or as a solution for injection.
Step 5
Follow-up assessments
Four weeks after the infusion, your pain levels will be reassessed using the NRS scale. Additional assessments may include questionnaires about your treatment experience, quality of life, and any side effects experienced.
Step 6
Completion of the study
Upon completing the study, you will have a final assessment to evaluate your overall experience and any changes in your condition. This information will contribute to the study's findings on the effectiveness of esketamine for managing chronic pain due to endometriosis.

Who can join the trial?

8 criteria

All pre-menopausal women aged above 18 years. Pre-menopausal means women who have not yet gone through menopause, the time when menstrual periods stop permanently.
Women diagnosed with endometriosis through ultrasound, MRI, or previous surgery. This diagnosis should follow the #Enzian classification, which includes specific areas in the body where endometriosis is present.
Experience mild to severe chronic pelvic pain with a score of 6 or higher on a pain scale from 0 to 10, where 0 means no pain and 10 means the worst pain imaginable.
Pain that does not improve with current recommended pain medications like paracetamol or NSAIDs (non-steroidal anti-inflammatory drugs).
Not using strong opioids for pain relief, or if they were used, they must have been stopped for more than 1 week.
Have a recommendation for surgery to remove endometriosis or are on a waiting list for such surgery.
Ability to understand the information about the study and provide both oral and written consent to participate.
No changes in the use of hormonal therapy within 1 month before joining the study.

Who cannot join the trial?

4 criteria

Patients who are not female cannot participate.
Patients who do not have a diagnosis of endometriosis cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Reinier de Graaf Groep
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Delft, The Netherlands

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Investigated drugs

Esketamine is a medication that is being tested in this clinical trial to see if it can help reduce chronic pelvic pain in patients with endometriosis. It is given as an infusion, which means it is delivered directly into the bloodstream over a period of time. The goal of using esketamine in this study is to see if it can lower the pain levels that patients experience, as measured by a pain rating scale. Esketamine is known for its effects on the brain, and researchers are exploring its potential benefits for managing chronic pain conditions.

What is already known about the treatment

Esketamine – Esketamine is administered as an infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied for its potential use in treating chronic pain associated with endometriosis, a condition where tissue similar to the lining inside the uterus grows outside of it, causing pain. The main therapeutic indication for esketamine in this study is to alleviate chronic pelvic pain. At the molecular level, esketamine works by blocking certain receptors in the brain, which can help reduce pain perception. It is classified pharmacologically as an anesthetic and is being explored for its pain-relieving properties in this context.

Investigated diseases

Endometriosis – Endometriosis is a condition where tissue similar to the lining inside the uterus, called endometrium, starts to grow outside the uterus. This tissue can be found on the ovaries, fallopian tubes, and the outer surface of the uterus, as well as other organs in the pelvis. The misplaced tissue continues to act as it normally would during the menstrual cycle, thickening, breaking down, and bleeding. However, because this tissue has no way to exit the body, it becomes trapped, leading to inflammation and the formation of scar tissue. Over time, this can cause pain, especially during menstruation, and may lead to fertility problems. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others suffering from severe pain.