Urinary StonePhase 2/3NCT04387617
A Study to Assess the Effect of Cannabidiol Oil on Pain After Ureteroscopy for Kidney Stones
A Phase 2/3 study testing Cannabidiol in people with Urinary Stone, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urinary Stone
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 31 Jan 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Current marijuana, cannabidiol (CBD), or dronabinol use.
- Liver disease/cirrhosis.
- Current treatment of seizures with clobazam, valproate, or other antiepileptic medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
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.
- Conditions
- Urinary Stone
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
PlaceboDrug
The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
| Study group | Role | What they receive |
|---|---|---|
| CBD Oil Group | Experimental | Not described Receives: Drug: Cannabidiol |
| Control Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative Day 3
Secondary outcomes (3)
Postoperative Rescue Narcotic Use
The number of subjects who required rescue narcotic use post ureteroscopy
Measured: 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.
Measured: postoperative day 1 and postoperative day 3
The Number of Subjects With Adverse Events
The count of subjects who experienced adverse events
Measured: 3 days post-ureteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start15 Feb 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary StoneStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen L. Stern, Mayo Clinic
- Investigators
- Karen Stern, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387617
- Sponsor's protocol ID
- 19-011832
- Status last verified
- Dec 2022
- First submitted
- 11 May 2020
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabidiol Oil on Postoperative Pain After Ureteroscopy for Urinary Calculi
- ClinicalTrials.gov ID
- NCT04387617
- Acronym / sponsor ID
- 19-011832
- Conditions
- Urinary Stone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Posted 18 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD Oil Group | Experimental | Drug: Cannabidiol |
| Control Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: EpidiolexThe product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days. | Drug | CBD Oil Group |
| PlaceboThe product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days | Drug | Control Group |
Primary outcome
Maximum Pain Intensity Score
Time frame: postoperative Day 3
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.
3 secondary outcomes
Postoperative Rescue Narcotic Use
Time frame: postoperative Day 3
Total Urinary Symptoms Score
Time frame: postoperative day 1 and postoperative day 3
The Number of Subjects With Adverse Events
Time frame: 3 days post-ureteroscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Stern, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol in people with Urinary Stone, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Pain Intensity Score (time frame: postoperative Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.