Back to resultsEffect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis (EdomTHC)
Primary Purpose
Endometriosis
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Cannabinoid treatment
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
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.
Sites / Locations
- Hospital Clínic de Barcelona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study arm
Arm Description
Participants are treated with the investigational medical product
Outcomes
Primary Outcome Measures
Pressure threshold in hypogastrium that induces pain
Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa
Secondary Outcome Measures
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.
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.
Intensity of the general pain
Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)
Anxiety and depression combined scale
Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).
Quality of Life
Quality of Life measured through the EQ-5D-5L questionnaire.
Central sensitivity
Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.
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).
about sleep quality
Visual analogue scale 0-10 about sleep quality
Full Information
NCT ID
NCT03875261
First Posted
March 6, 2019
Last Updated
March 13, 2019
Sponsor
David Garcia Cinca
Collaborators
Fundació Clínic per la Recerca Biomedica, Dr. Christian Dursteler
1. Study Identification
Unique Protocol Identification Number
NCT03875261
Brief Title
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Acronym
EdomTHC
Official Title
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
July 15, 2019 (Anticipated)
Study Completion Date
July 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Garcia Cinca
Collaborators
Fundació Clínic per la Recerca Biomedica, Dr. Christian Dursteler
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the treatment of the symptoms of deep endometriosis with a cannabinoid derivate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study arm
Arm Type
Experimental
Arm Description
Participants are treated with the investigational medical product
Intervention Type
Drug
Intervention Name(s)
Cannabinoid treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure threshold in hypogastrium that induces pain
Description
Pain threshold versus mechanical stimulation in hypogastrium (anterior central L2 dermatoma) measured in kPa
Time Frame
day 30 after treatment initiation
Secondary Outcome Measure Information:
Title
Pressure threshold in dermatomes that induces pain
Description
Umbral of pain versus mechanical stimulation in dermatomes L2 anterior, L2 posterior, and T1 of the dominant upper extremity.
Time Frame
baseline, day 15, day 30 and day 45
Title
Temperature threshold in dermatomes that induces pain
Description
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.
Time Frame
baseline, day 15, day 30 and day 45
Title
Intensity of the general pain
Description
Intensity of the general pain associated with endometriosis measured by a visual analogue scale (0-10)
Time Frame
baseline, day 15, day 30 and day 45
Title
Anxiety and depression combined scale
Description
Anxiety and depression measured with the Scale of Anxiety and Hospital Depression Scale (HADS).
Time Frame
baseline, day 15, day 30 and day 45
Title
Quality of Life
Description
Quality of Life measured through the EQ-5D-5L questionnaire.
Time Frame
baseline, day 15, day 30 and day 45
Title
Central sensitivity
Description
Central sensitivity measured with the Central Sensitization Inventory (CSI) questionnaire.
Time Frame
baseline, day 15, day 30 and day 45
Title
Cognitive disorder measured by a list of words
Description
Cognitive disorder measured by a list of words (immediate memory and retention) and digits (attentional capacity) of the Wechsler Memory Scale (WMS-III).
Time Frame
baseline, day 15, day 30 and day 45
Title
about sleep quality
Description
Visual analogue scale 0-10 about sleep quality
Time Frame
baseline, day 15, day 30 and day 45
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Dursteler, MD
Phone
+34.93.227.54.00
Email
dursteler@clinic.cat
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Dursteler, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
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