Trial · NCT03941288

Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

NCT03941288, Phase 2, Completed, Mayo Clinic; results first posted 2024-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia. Trials, record NCT03941288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03941288

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
NCT number: NCT03941288
Status: Completed
Phases: Phase 2
Enrollment: 92 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Gastroparesis, Dyspepsia
Interventions: Cannabidiol, placebo
First posted: 2019-05-07
Last updated: 2024-02-13
Results first posted: 2024-02-13

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Gastric Emptying Half-time (T1/2) of Solids	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.
Primary	Gastric Emptying Lag Time (T-lag) of Solids	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.
Primary	Fasting Gastric Volume	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).
Primary	Gastric Accommodation	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).
Primary	Satiation Volume to Fullness	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.
Primary	Satiation Maximum Tolerated Volume (MTV)	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.
Secondary	Weekly Global Symptom Assessment	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?".
Secondary	Mean Daily Symptom Score in Functional Dyspepsia	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.
Secondary	Mean Daily Epigastric Pain in Functional Dyspepsia	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.
Secondary	Quality of Life in Functional Dyspepsia	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Gastric Emptying Half-time (T1/2) of Solids	4 weeks	minutes	MEDIAN
PRIMARY	Gastric Emptying Lag Time (T-lag) of Solids	4 weeks	minutes	MEDIAN
PRIMARY	Fasting Gastric Volume	4 weeks	mL	MEDIAN
PRIMARY	Gastric Accommodation	4 weeks	mL	MEDIAN
PRIMARY	Satiation Volume to Fullness	4 weeks	mL	MEDIAN
PRIMARY	Satiation Maximum Tolerated Volume (MTV)	4 weeks	mL	MEDIAN
SECONDARY	Weekly Global Symptom Assessment	4 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Daily Symptom Score in Functional Dyspepsia	4 weeks	score on a scale	MEDIAN
SECONDARY	Mean Daily Epigastric Pain in Functional Dyspepsia	4 weeks	score on a scale	MEDIAN
SECONDARY	Quality of Life in Functional Dyspepsia	4 weeks	score on a scale	MEDIAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Gastric Emptying Half-time (T1/2) of Solids	Functional Dyspepsia - Cannabidiol	128.7	Inter-Quartile Range 112.3 to 150.5	minutes
Gastric Emptying Half-time (T1/2) of Solids	Functional Dyspepsia - Placebo	125.8	Inter-Quartile Range 120.2 to 142.2	minutes
Gastric Emptying Half-time (T1/2) of Solids	Gastroparesis - Canabidiol	246.4	Inter-Quartile Range 172.1 to 312.9	minutes
Gastric Emptying Half-time (T1/2) of Solids	Gastroparesis - Placebo	198.4	Inter-Quartile Range 148.9 to 241.3	minutes
Gastric Emptying Lag Time (T-lag) of Solids	Functional Dyspepsia - Cannabidiol	46.0	Inter-Quartile Range 34.3 to 60.0	minutes
Gastric Emptying Lag Time (T-lag) of Solids	Functional Dyspepsia - Placebo	52.1	Inter-Quartile Range 30.0 to 64.2	minutes
Gastric Emptying Lag Time (T-lag) of Solids	Gastroparesis - Canabidiol	83.0	Inter-Quartile Range 67.5 to 128.0	minutes
Gastric Emptying Lag Time (T-lag) of Solids	Gastroparesis - Placebo	60.8	Inter-Quartile Range 35.0 to 94.0	minutes
Fasting Gastric Volume	Functional Dyspepsia - Cannabidiol	179.0	Inter-Quartile Range 161.1 to 212.0	mL
Fasting Gastric Volume	Functional Dyspepsia - Placebo	214.5	Inter-Quartile Range 173.7 to 263.8	mL

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Functional Dyspepsia - Cannabidiol	25
Overall Study	STARTED	Functional Dyspepsia - Placebo	23
Overall Study	STARTED	Gastroparesis - Canabidiol	21
Overall Study	STARTED	Gastroparesis - Placebo	23
Overall Study	COMPLETED	Functional Dyspepsia - Cannabidiol	22
Overall Study	COMPLETED	Functional Dyspepsia - Placebo	21
Overall Study	COMPLETED	Gastroparesis - Canabidiol	20
Overall Study	COMPLETED	Gastroparesis - Placebo	22
Overall Study	NOT COMPLETED	Functional Dyspepsia - Cannabidiol	3
Overall Study	NOT COMPLETED	Functional Dyspepsia - Placebo	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	Functional Dyspepsia - Cannabidiol	8	25	8
other	Fatigue	General disorders	Functional Dyspepsia - Placebo	8	23	8
other	Fatigue	General disorders	Gastroparesis - Canabidiol	4	21	4
other	Fatigue	General disorders	Gastroparesis - Placebo	4	23	4
other	Nausea	General disorders	Functional Dyspepsia - Cannabidiol	8	25	8
other	Nausea	General disorders	Functional Dyspepsia - Placebo	8	23	8
other	Nausea	General disorders	Gastroparesis - Canabidiol	3	21	3
other	Nausea	General disorders	Gastroparesis - Placebo	4	23	4
other	Diarrhea	General disorders	Functional Dyspepsia - Cannabidiol	8	25	8
other	Diarrhea	General disorders	Functional Dyspepsia - Placebo	1	23	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Functional Dyspepsia - Cannabidiol	0	25
Total, all-cause mortality	Functional Dyspepsia - Placebo	0	23
Total, all-cause mortality	Gastroparesis - Canabidiol	0	21
Total, all-cause mortality	Gastroparesis - Placebo	0	23
Total, other adverse events	Functional Dyspepsia - Cannabidiol	11	25
Total, other adverse events	Functional Dyspepsia - Placebo	8	23
Total, other adverse events	Gastroparesis - Canabidiol	19	21
Total, other adverse events	Gastroparesis - Placebo	10	23
Total, serious adverse events	Functional Dyspepsia - Cannabidiol	0	25
Total, serious adverse events	Functional Dyspepsia - Placebo	0	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35537858	DERIVED	PubMed
37482172	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DK122280	Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia	CAMILLERI, MICHAEL L.	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019 to 2022

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Functional Dyspepsia - Cannabidiol vs Functional Dyspepsia - Placebo: Weekly Global Symptom Assessment

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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