Trial Outcomes & Findings for Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia (NCT NCT03941288)

NCT ID: NCT03941288

Last Updated: 2024-02-13

Results Overview

Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying (GE t 1/2) was measured by scintigraphy and defined as the time required for 50% of the radiolabeled tracer to empty from the stomach.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-02-13

Participant Flow

Participant milestones

Measure	Functional Dyspepsia - Cannabidiol Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Overall Study STARTED	25	23	21	23
Overall Study COMPLETED	22	21	20	22
Overall Study NOT COMPLETED	3	2	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Baseline characteristics by cohort

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.	Total n=92 Participants Total of all reporting groups
Age, Continuous	34.5 years n=5 Participants	35.0 years n=7 Participants	44.0 years n=5 Participants	44.0 years n=4 Participants	37.0 years n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	20 Participants n=4 Participants	75 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	23 Participants n=4 Participants	88 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment United States	25 participants n=5 Participants	23 participants n=7 Participants	21 participants n=5 Participants	23 participants n=4 Participants	92 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying (GE t 1/2) was measured by scintigraphy and defined as the time required for 50% of the radiolabeled tracer to empty from the stomach.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Gastric Emptying Half-time (T1/2) of Solids	128.7 minutes Interval 112.3 to 150.5	125.8 minutes Interval 120.2 to 142.2	246.4 minutes Interval 172.1 to 312.9	198.4 minutes Interval 148.9 to 241.3

PRIMARY outcome

Timeframe: 4 weeks

Subjects ingested a Technetium-99m sulfur colloid radiolabeled meal and Indium-111 absorbed on to activated charcoal particles and delivered to the colon by an oral methacrylate-coated capsule. Gastric emptying lag time (GE t-lag) was measured by scintigraphy and defined as the amount of time the radioactive meal was in the stomach before starting to empty into the small bowel.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Gastric Emptying Lag Time (T-lag) of Solids	46.0 minutes Interval 34.3 to 60.0	52.1 minutes Interval 30.0 to 64.2	83.0 minutes Interval 67.5 to 128.0	60.8 minutes Interval 35.0 to 94.0

PRIMARY outcome

Timeframe: 4 weeks

Gastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Fasting Gastric Volume	179.0 mL Interval 161.1 to 212.0	214.5 mL Interval 173.7 to 263.8	235.6 mL Interval 170.8 to 319.0	220.3 mL Interval 187.2 to 292.2

PRIMARY outcome

Timeframe: 4 weeks

Gastric accommodation was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Gastric Accommodation	410.2 mL Interval 324.9 to 451.1	417.5 mL Interval 318.7 to 473.6	440.6 mL Interval 392.8 to 467.8	415.5 mL Interval 353.2 to 456.0

PRIMARY outcome

Timeframe: 4 weeks

Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min. Participants recorded their sensations every 5 minutes using a numeric scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the MTV (maximum or unbearable fullness/satiation). Nutrient intake was stopped when subjects reach a score of 5.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Satiation Volume to Fullness	373.3 mL Interval 373.3 to 559.9	622.1 mL Interval 373.3 to 746.6	682.6 mL Interval 631.2 to 826.5	638.2 mL Interval 575.3 to 710.7

PRIMARY outcome

Timeframe: 4 weeks

Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min. Participants recorded their sensations every 5 minutes using a numeric scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the MTV (maximum or unbearable fullness/satiation). Nutrient intake was stopped when subjects reach a score of 5.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Satiation Maximum Tolerated Volume (MTV)	808.8 mL Interval 435.8 to 995.4	871.0 mL Interval 497.7 to 1119.8	1061.6 mL Interval 812.7 to 1310.4	812.7 mL Interval 688.3 to 1061.6

SECONDARY outcome

Timeframe: 4 weeks

The number of functional dyspepsia participants who confirmed adequate relief of dyspepsia symptoms, based on the self-reporting question "In the past 7 days have you had adequate relief of your upper abdominal pain or discomfort?".

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Weekly Global Symptom Assessment	12 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: 4 weeks

Self-reported daily symptom diaries assessed 3 symptoms of functional dyspepsia: (1) upper abdominal pain, (2) nausea, and (3) bloating or distension. Each symptom was scored from 0-4, where 0=none, 1= very mild, 2=mild, 3=moderate, and 4=severe. The responses were averaged together to provide an overall symptom score, which ranged from 0-4, where a higher score reflects worse symptoms.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Mean Daily Symptom Score in Functional Dyspepsia	1.2 score on a scale Interval 0.9 to 2.0	1.1 score on a scale Interval 0.8 to 2.0	—	—

SECONDARY outcome

Timeframe: 4 weeks

Mean daily epigastric pain in functional dyspepsia participants as measured by the question "How much did you suffer from pain in your stomach area today?". The score is based on 5 point scale ranging from 0 (not at all) to 5 (extremely) where a higher score reflects more pain.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Mean Daily Epigastric Pain in Functional Dyspepsia	0.7 score on a scale Interval 0.1 to 1.3	0.8 score on a scale Interval 0.3 to 1.1	—	—

SECONDARY outcome

Timeframe: 4 weeks

The Nepean Dyspepsia Index (NDI) is used to assess functional dyspepsia quality of life. NDI scores are summarized as overall quality of life based on 5 subscales: interference, knowledge/control, eating/drinking, sleep disturbance, work/study. There are two questions per subscale for a total of 10 questions. Each question is ranked from 0-4, where 0 is 'not at all' and 4 is 'extremely'. The results from each question are added together to generate a total index score of 0 to 40. A lower score reflects no to little impact functional dyspepsia has on on quality of life while a higher score reflects significant impact functional dyspepsia has on quality of life.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Quality of Life in Functional Dyspepsia	4.4 score on a scale Interval 3.2 to 5.0	3.6 score on a scale Interval 3.0 to 4.7	—	—

SECONDARY outcome

Timeframe: 4 weeks

Postprandial symptoms of fullness, nausea, bloating, and pain were measured 30min after the satiation drink test using 100mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. Scores for each symptom were added to calculate the aggregate symptom score, which ranged from 0-400, where a lower score reflected mild symptoms and a higher score reflected more severe symptoms.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=25 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 Participants Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 Participants Placebo will be administered to participants with gastroparesis 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.
Aggregate Symptom Score	182.5 score on a scale Interval 132.5 to 253.0	219.0 score on a scale Interval 184.0 to 250.0	243.0 score on a scale Interval 234.0 to 313.0	264.5 score on a scale Interval 225.0 to 320.0

SECONDARY outcome

Timeframe: 4 weeks

Overall severity in gastroparesis was self-measured daily by asking the question "In thinking about your gastroparesis disorder, what was the overall severity of your gastroparesis symptoms today (during the past 24 hours)"? The responses were ranked as 0 (none), 1 (mild), 2 (moderate), 3 (severe) and 4 (very severe). Scores range from 0-4, where 0 reflects little to no severity of symptoms and 4 reflects severe symptoms.

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=21 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Overall Severity in Gastroparesis	1.8 score on a scale Interval 1.3 to 2.5	1.6 score on a scale Interval 1.2 to 3.1	—	—

SECONDARY outcome

Timeframe: 4 weeks

The average daily number of vomiting episodes in gastroparesis was measured by participants self-reporting responses to the question "In the past 24 hours how many episodes of vomiting did you have?"

Outcome measures

Measure	Functional Dyspepsia - Cannabidiol n=21 Participants Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 Participants Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo Placebo will be administered to participants with gastroparesis 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.
Average Daily Vomiting Episodes in Gastroparesis	0.0 vomiting episodes/day Interval 0.0 to 0.1	0.2 vomiting episodes/day Interval 0.0 to 0.5	—	—

Adverse Events

Functional Dyspepsia - Cannabidiol

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Functional Dyspepsia - Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Gastroparesis - Canabidiol

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Gastroparesis - Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Functional Dyspepsia - Cannabidiol n=25 participants at risk Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 participants at risk Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 participants at risk Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 participants at risk Placebo will be administered to participants with gastroparesis 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.
General disorders Abdominal lacerations	0.00% 0/25 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	0.00% 0/23 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	4.8% 1/21 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	0.00% 0/23 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.
General disorders Appendectomy	0.00% 0/25 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	0.00% 0/23 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	4.8% 1/21 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	0.00% 0/23 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.

Other adverse events

Measure	Functional Dyspepsia - Cannabidiol n=25 participants at risk Cannabidiol will be administered to participants with functional dyspepsia 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.	Functional Dyspepsia - Placebo n=23 participants at risk Placebo will be administered to participants with functional dyspepsia 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.	Gastroparesis - Canabidiol n=21 participants at risk Cannabidiol will be administered to participants with gastroparesis 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.	Gastroparesis - Placebo n=23 participants at risk Placebo will be administered to participants with gastroparesis 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.
General disorders Fatigue	32.0% 8/25 • Number of events 8 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	34.8% 8/23 • Number of events 8 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	19.0% 4/21 • Number of events 4 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	17.4% 4/23 • Number of events 4 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.
General disorders Nausea	32.0% 8/25 • Number of events 8 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	34.8% 8/23 • Number of events 8 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	14.3% 3/21 • Number of events 3 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	17.4% 4/23 • Number of events 4 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.
General disorders Diarrhea	32.0% 8/25 • Number of events 8 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	4.3% 1/23 • Number of events 1 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	57.1% 12/21 • Number of events 12 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.	8.7% 2/23 • Number of events 2 • Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.

Additional Information

Michael Camilleri, MD

Mayo Clinic

Phone: 507-266-2305

Email: camilleri.michael@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place