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

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ClinicalTrials.gov Identifier: NCT03875261
Recruitment Status : Unknown
Verified March 2019 by David Garcia Cinca, Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Fundació Clínic per la Recerca Biomedica
Dr. Christian Dursteler
Information provided by (Responsible Party):
David Garcia Cinca, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Cannabinoid treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pressure threshold in hypogastrium that induces pain [ Time Frame: day 30 after treatment initiation ]
    Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa


Secondary Outcome Measures :
  1. Pressure threshold in dermatomes that induces pain [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity.

  2. Temperature threshold in dermatomes that induces pain [ Time Frame: baseline, day 15, day 30 and day 45 ]
    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.

  3. Intensity of the general pain [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)

  4. Anxiety and depression combined scale [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).

  5. Quality of Life [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Quality of Life measured through the EQ-5D-5L questionnaire.

  6. Central sensitivity [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.

  7. Cognitive disorder measured by a list of words [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III).

  8. about sleep quality [ Time Frame: baseline, day 15, day 30 and day 45 ]
    Visual analogue scale 0-10 about sleep quality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875261


Contacts
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Contact: Christian Dursteler, MD +34.93.227.54.00 dursteler@clinic.cat

Locations
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Spain
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain, 08036
Contact: Christian Dursteler, MD         
Sponsors and Collaborators
David Garcia Cinca
Fundació Clínic per la Recerca Biomedica
Dr. Christian Dursteler
More Information
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Responsible Party: David Garcia Cinca, Clinical Research Manager, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03875261    
Other Study ID Numbers: 2018-004378-92
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperalgesia
Endometriosis
Somatosensory Disorders
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases