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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD Oil Group | Experimental |
| |
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pain Intensity Score | Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. | postoperative Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Rescue Narcotic Use | The number of subjects who required rescue narcotic use post ureteroscopy | postoperative Day 3 |
| Total Urinary Symptoms Score | Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Stern, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBD Oil Group | Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days. |
| FG001 | Control Group | Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CBD Oil Group | Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days. |
| BG001 | Control Group | Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Pain Intensity Score | Patient self-reported maximum pain intensity score measured by the Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | postoperative Day 3 |
|
Adverse events were collected from each subject from baseline to end of study for a total of 3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBD Oil Group | Cannabidiol: The product is a liquid formulation that was prescribed at a dosage of 20 mg per day for a total of 3 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen L. Stern, M.D. | Mayo Clinic | 480-342-3868 | Stern.Karen@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2020 | Nov 10, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days |
|
| postoperative day 1 and postoperative day 3 |
| The Number of Subjects With Adverse Events | The count of subjects who experienced adverse events | 3 days post-ureteroscopy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Postoperative Rescue Narcotic Use | The number of subjects who required rescue narcotic use post ureteroscopy | Posted | Count of Participants | Participants | postoperative Day 3 |
|
|
|
| Secondary | Total Urinary Symptoms Score | Patient self-reported urinary symptoms measured by the Ureteric Stent Symptoms Questionnaire (USSQ) urinary symptoms section. Following insertion of the stents, subjects were asked to answer 11 questions regarding their urinary symptoms. 9 questions used a score of 1 to 5, where 1 was never and 5 was all of the time. 1 question used a score of 1 to 4, where 1 was do not see any blood and 4 was urine is heavily blood stained. 1 question used a score of 1 to 7, where 1 was delighted and 7 was terrible. Total sum of all 11 questions for a total score ranging from 11 - 56, lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction. | Posted | Mean | Standard Deviation | score on a scale | postoperative day 1 and postoperative day 3 |
|
|
|
| Secondary | The Number of Subjects With Adverse Events | The count of subjects who experienced adverse events | Posted | Count of Participants | Participants | 3 days post-ureteroscopy |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 24 |
| 45 |
| EG001 | Control Group | Placebo: The product is a liquid formulation placebo that was prescribed at an equivalent volume as active drug for 3 days | 0 | 45 | 0 | 45 | 21 | 45 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Poor Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Poor sleep | Psychiatric disorders | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Tiredness | General disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Diarrhea |
|
| Poor appetite |
|
| Poor sleep |
|
| Drowiness |
|
| Dizziness |
|
| Tiredness |
|
| Itching |
|
| Headache |
|