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Cannabinoid

Pharmacodynamics and clinical effects of cannabidiol for Gastroparesis

Phase 2

Waitlist Available

Led By Michael Camilleri, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial will see if a cannabidiol medication can help improve stomach function in people with gastroparesis or dyspepsia.

Eligible Conditions

Gastroparesis
Indigestion

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fasting Gastric Volume

Gastric Accommodation

Gastric Emptying Half-time (T1/2) of Solids

+3 more

Secondary outcome measures

Aggregate Symptom Score

Average Daily Vomiting Episodes in Gastroparesis

Mean Daily Epigastric Pain in Functional Dyspepsia

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Pharmacodynamics and clinical effects of cannabidiolActive Control1 Intervention

Cannabidiol will be administered orally twice daily in equally divided doses starting at 2.5mg/kg per day and increasing by 2.5 to 5.0mg/kg every other day until the target dose of 20mg/kg is reached. Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.

Group II: pharmacodynamics and clinical effects of placeboPlacebo Group1 Intervention

Placebo will be administered orally twice daily in equally divided doses starting at 2.5mg/kg per day and increasing by 2.5 to 5.0mg/kg every other day until the target dose of 20mg/kg is reached. Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,766,991 Total Patients Enrolled

9 Trials studying Gastroparesis

535 Patients Enrolled for Gastroparesis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,094 Total Patients Enrolled

19 Trials studying Gastroparesis

3,327 Patients Enrolled for Gastroparesis

Michael Camilleri, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus

University Of Malta (Medical School)

(Residency)

38 Previous Clinical Trials

3,180 Total Patients Enrolled

3 Trials studying Gastroparesis

74 Patients Enrolled for Gastroparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can seniors participate in this research project?

"The minimum age requirement for this trial is 18 and the maximum is 70."

Answered by AI

Has the FDA looked into cannabidiol's therapeutic potential?

"While there is some evidence from phase 2 trials to support the safety of CBD, efficacy has not been observed in these studies. Therefore, it received a score of 2."

Answered by AI

Could you explain the research that has been conducted on how cannabidiol affects patients?

"Out of the 83 total ongoing trials investigating Pharmacodynamics and clinical effects of cannabidiol, 18 are currently in Phase 3. Many of these clinical trials are being conducted in Brazil - specifically Ribeirao Preto and Sao Paulo - but there are also 311 other locations running similar studies."

Answered by AI

How many individuals are being asked to take part in this research?

"Yes, as indicated by the clinicaltrials.gov listing, this trial is currently looking for enrollees. The listing also shows that the study was posted on September 4th, 2019 and updated on May 23rd, 2022. 96 patients will be accepted from a single location."

Answered by AI

Could I potentially take part in this particular research project?

"Individuals with gastroparesis that are between 18-70 years old may be eligible for this study. Currently, the research team is looking to recruit 96 patients in total."

Answered by AI

Are subjects being recruited for this experiment at this time?

"The study, which was originally posted on September 4th 2019, is still actively recruiting patients according to the information available clinicaltrials.gov. The last update to the posting was on May 23rd 2022."

Answered by AI

What goals has this clinical trial set out to achieve?

"The purpose of this 4-week trial, which will use a daily diary to collect data, is to assess the primary endpoint of satiation. Additionally, secondary outcomes including symptom scores during gastric emptying test, maximum tolerated volume (mL), and aggregate symptoms will be measured."

Answered by AI