Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis (EdomTHC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03875261|
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: Cannabinoid treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
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
|Contact: Christian Dursteler, MDfirstname.lastname@example.org|
|Hospital Clínic de Barcelona|
|Barcelona, Catalonia, Spain, 08036|
|Contact: Christian Dursteler, MD|