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Trial record 41 of 250 for:    epidiolex

A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones

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: NCT04387617
Recruitment Status : Not yet recruiting
First Posted : May 14, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Karen L. Stern, Mayo Clinic

Brief Summary:
The purpose of this study is to determine if CBD oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if CBD oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.

Condition or disease Intervention/treatment Phase
Urinary Stone Drug: Cannabidiol Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBD Oil Group Drug: Cannabidiol
The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
Other Name: Epidiolex

Placebo Comparator: Control Group Drug: Placebo
The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days




Primary Outcome Measures :
  1. Post operative Pain intensity [ Time Frame: 3 days post-ureteroscopy ]
    Patient self-reported pain intensity score using a 100 mm visual analog scale


Secondary Outcome Measures :
  1. Postoperative opioid use [ Time Frame: 3 days post-ureteroscopy ]
    Total dosage of opioids used by patients

  2. Ureteric stent symptoms [ Time Frame: 1 and 3 days post-ureteroscopy ]
    Ureteric stent Symptoms Questionnaire

  3. Side effects and adverse events [ Time Frame: 3 days post-ureteroscopy ]
    post operative adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are diagnosed with kidney or ureteral stones confirmed on imaging (CT of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution.
  • Age 18-75 years of age.
  • Patients of either gender.
  • Patients of all ethnic backgrounds.
  • Capable of giving informed consent.
  • Capable and willing to fulfill the requirements of the study.

Exclusion Criteria:

  • History of chronic pain.
  • Chronic use of opioid or other pain medication (> 12 weeks).
  • Known allergy to CBD oil or other cannabinoids.
  • Known or suspected pregnancy.
  • Inability to give informed consent or unable to meet requirements of the study for any reason.
  • Bilateral ureteroscopy.
  • Current marijuana, cannabidiol (CBD), or dronabinol use.
  • Liver disease/cirrhosis.
  • Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.

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): NCT04387617


Locations
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United States, Arizona
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Karen Stern, MD Mayo Clinic
Additional Information:
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Responsible Party: Karen L. Stern, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04387617    
Other Study ID Numbers: 19-011832
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Calculi
Urolithiasis
Urologic Diseases
Calculi
Pathological Conditions, Anatomical
Epidiolex
Anticonvulsants