Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis (EdomTHC)

This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Cannabinoid treatment

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christian Dursteler, MD; Phone Number: +34.93.227.54.00; Email: dursteler@clinic.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Hospital Clinic de Barcelona
      • Contact: Christian Dursteler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women between the ages of 18 and 40.
• Diagnosis of deep endometriosis after clinical suspicion and confirmation by imaging test.
• Pain with a score of 4 or more on a numerical visual scale of 11 levels (EVN 0-10) in the last 3 months (includes any type of pain associated with endometriosis: dysmenorrhea, dyspareunia, dyschezia, dysuria and / or pelvic pain).
• Women of childbearing age * should have a negative pregnancy test before inclusion in the study and should commit to using highly effective contraceptive methods (hormonal contraceptives, intrauterine device, intrauterine hormonal release systems, bilateral tubal occlusion, vasectomy the couple, barrier methods and sexual abstinence) during the entire duration of the study and up to 3 months after the end of it.
• Acceptance of participation in the study by signing the informed consent.

Exclusion Criteria:

• Patients previously submitted to open abdominal surgery.
• History of cancer.
• Suspicion or diagnosis of endocrine, cardio-vascular or systemic pathology relevant.
• Pregnancy or anticipation of pregnancy up to 3 months after the end of the study.
• Current breastfeeding.
• Use of hormonal treatment (combined oral contraception, progestin in the 3 months prior to the study, GNRH analogs in the 6 months prior to the start of the study).
• Use of other analgesics different from those allowed in the study.
• Recreational or pharmacological use of cannabinoids.
• Hypersensitivity to cannabinoids or any of the exceptions.
• Known or suspected personal history, or family history of schizophrenia or other psychotic illnesses, severe personality disorder or other major psychiatric disorders.
• Patients with liver or kidney failure, severe cardiovascular disease and a history of epilepsy or recurrent seizures.
• Patients who use concomitant potent enzyme inducers of CYP3A4, such as rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Participants are treated with the investigational medical product	Drug: Cannabinoid treatment; Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure threshold in hypogastrium that induces pain	Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa	day 30 after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure threshold in dermatomes that induces pain	Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity.	baseline, day 15, day 30 and day 45
Temperature threshold in dermatomes that induces pain	Umbral sensation versus thermal stimulus (cold heat) in anterior central L2 dermatomes, posterior central L2, and T1 of the dominant upper extremity. Measured in ºC.	baseline, day 15, day 30 and day 45
Intensity of the general pain	Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)	baseline, day 15, day 30 and day 45
Anxiety and depression combined scale	Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).	baseline, day 15, day 30 and day 45
Quality of Life	Quality of Life measured through the EQ-5D-5L questionnaire.	baseline, day 15, day 30 and day 45
Central sensitivity	Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.	baseline, day 15, day 30 and day 45
Cognitive disorder measured by a list of words	Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III).	baseline, day 15, day 30 and day 45
about sleep quality	Visual analogue scale 0-10 about sleep quality	baseline, day 15, day 30 and day 45

Collaborators and Investigators

• Sponsor: David Garcia Cinca
• Collaborators: Fundació Clínic per la Recerca Biomedica; Dr. Christian Dursteler

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): July 15, 2019
• Study Completion (Anticipated): July 15, 2019

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Endometriosis; Hyperalgesia
• Other Study ID Numbers: 2018-004378-92

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No