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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

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Cannabinoid (THC / CBD 50%) on Hyperalgesia in Patients With Deep Endometriosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE 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  ICMJE Experimental: Study arm
Participants are treated with the investigational medical product
Intervention: Drug: Cannabinoid treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875261
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party David Garcia Cinca, Hospital Clinic of Barcelona
Original Responsible Party Same as current
Current Study Sponsor  ICMJE David Garcia Cinca
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Fundació Clínic per la Recerca Biomedica
  • Dr. Christian Dursteler
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP