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

• ClinicalTrials.gov Identifier: NCT03875261
• Recruitment Status: Unknown
• First Posted: March 14, 2019
• Last Update Posted: March 14, 2019
• Sponsor: David Garcia Cinca
• Collaborators: Fundació Clínic per la Recerca Biomedica; Dr. Christian Dursteler
• Information provided by (Responsible Party): David Garcia Cinca, Hospital Clinic of Barcelona

Tracking Information

• First Submitted Date: March 6, 2019
• First Posted Date: March 14, 2019
• Last Update Posted Date: March 14, 2019
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: July 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 13, 2019)

• 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.
• 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.
• 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)
• 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).
• Quality of Life [ Time Frame: baseline, day 15, day 30 and day 45 ]
  Quality of Life measured through the EQ-5D-5L questionnaire.
• Central sensitivity [ Time Frame: baseline, day 15, day 30 and day 45 ]
  Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.
• 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).
• about sleep quality [ Time Frame: baseline, day 15, day 30 and day 45 ]
  Visual analogue scale 0-10 about sleep quality

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
• Official Title: Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
• Brief Summary: This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Endometriosis

Intervention

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.

Study Arms

Experimental: Study arm

Participants are treated with the investigational medical product

Intervention: Drug: Cannabinoid treatment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 13, 2019): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 15, 2019
• Estimated Primary Completion Date: July 15, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03875261
• Other Study ID Numbers: 2018-004378-92
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: David Garcia Cinca, Hospital Clinic of Barcelona
• Original Responsible Party: Same as current
• Current Study Sponsor: David Garcia Cinca
• Original Study Sponsor: Same as current

Collaborators

• Fundació Clínic per la Recerca Biomedica
• Dr. Christian Dursteler

• Investigators: Not Provided
• PRS Account: Hospital Clinic of Barcelona
• Verification Date: March 2019