NCT03941288

Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Completed Phase 2 Results posted Last updated 13 February 2024

What this trial tests

Phase 2 trial testing Cannabidiol in Gastroparesis in 92 participants. Completed in 23 February 2023.

Timeline

4 September 2019

Primary endpoint
23 February 2023

23 February 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	92
Start date	4 September 2019
Primary completion	23 February 2023
Estimated completion	23 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Cannabidiol (CANNABIDIOL) — full drug profile →
• placebo

Conditions studied

• Gastroparesis — all drugs for Gastroparesis →
• Dyspepsia — all drugs for Dyspepsia →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 70, any sex, with Gastroparesis or Dyspepsia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	128.7	112.3 – 150.5
Functional Dyspepsia - Placebo	125.8	120.2 – 142.2
Gastroparesis - Canabidiol	246.4	172.1 – 312.9
Gastroparesis - Placebo	198.4	148.9 – 241.3

Gastric Emptying Lag Time (T-lag) of Solids Primary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	46.0	34.3 – 60.0
Functional Dyspepsia - Placebo	52.1	30.0 – 64.2
Gastroparesis - Canabidiol	83.0	67.5 – 128.0
Gastroparesis - Placebo	60.8	35.0 – 94.0

Fasting Gastric Volume Primary · 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).

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	179.0	161.1 – 212.0
Functional Dyspepsia - Placebo	214.5	173.7 – 263.8
Gastroparesis - Canabidiol	235.6	170.8 – 319.0
Gastroparesis - Placebo	220.3	187.2 – 292.2

Gastric Accommodation Primary · 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).

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	410.2	324.9 – 451.1
Functional Dyspepsia - Placebo	417.5	318.7 – 473.6
Gastroparesis - Canabidiol	440.6	392.8 – 467.8
Gastroparesis - Placebo	415.5	353.2 – 456.0

Satiation Volume to Fullness Primary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	373.3	373.3 – 559.9
Functional Dyspepsia - Placebo	622.1	373.3 – 746.6
Gastroparesis - Canabidiol	682.6	631.2 – 826.5
Gastroparesis - Placebo	638.2	575.3 – 710.7

Satiation Maximum Tolerated Volume (MTV) Primary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	808.8	435.8 – 995.4
Functional Dyspepsia - Placebo	871.0	497.7 – 1119.8
Gastroparesis - Canabidiol	1061.6	812.7 – 1310.4
Gastroparesis - Placebo	812.7	688.3 – 1061.6

Weekly Global Symptom Assessment Secondary · 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?".

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	12
Functional Dyspepsia - Placebo	11

Mean Daily Symptom Score in Functional Dyspepsia Secondary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	1.2	0.9 – 2.0
Functional Dyspepsia - Placebo	1.1	0.8 – 2.0

Mean Daily Epigastric Pain in Functional Dyspepsia Secondary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	0.7	0.1 – 1.3
Functional Dyspepsia - Placebo	0.8	0.3 – 1.1

Quality of Life in Functional Dyspepsia Secondary · 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 refl

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	4.4	3.2 – 5.0
Functional Dyspepsia - Placebo	3.6	3.0 – 4.7

Aggregate Symptom Score Secondary · 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.

Group	Value	95% CI
Functional Dyspepsia - Cannabidiol	182.5	132.5 – 253.0
Functional Dyspepsia - Placebo	219.0	184.0 – 250.0
Gastroparesis - Canabidiol	243.0	234.0 – 313.0
Gastroparesis - Placebo	264.5	225.0 – 320.0

Overall Severity in Gastroparesis Secondary · 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.

Group	Value	95% CI
Gastroparesis - Canabidiol	1.8	1.3 – 2.5
Gastroparesis - Placebo	1.6	1.2 – 3.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each subject from baseline until 30 days after the last day of study medication, for approximately two months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Functional Dyspepsia - Cannabidiol

Serious: 0/25 (0%)

Deaths: 0/25

Functional Dyspepsia - Placebo

Serious: 0/23 (0%)

Deaths: 0/23

Gastroparesis - Canabidiol

Serious: 2/21 (10%)

Deaths: 0/21

Gastroparesis - Placebo

Serious: 0/23 (0%)

Deaths: 0/23

Serious adverse events (2 terms)

Reaction	System	Functional Dyspepsia - Can…	Functional Dyspepsia - Pla…	Gastroparesis - Canabidiol	Gastroparesis - Placebo
Abdominal lacerations	General disorders	—	—	—	—
Appendectomy	General disorders	—	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Functional Dyspepsia - Can…	Functional Dyspepsia - Pla…	Gastroparesis - Canabidiol	Gastroparesis - Placebo
Diarrhea	General disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Nausea	General disorders	—	—	—	—

Most-reported serious reactions: Abdominal lacerations, Appendectomy.

Data from ClinicalTrials.gov NCT03941288 adverse events section.

Sponsor's own description

Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach's muscles or nerves).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of Gastroparesis.
   Zheng T, Camilleri M. · · 2021 · cited 24× · PMID 35466306
2. Pharmacology, Clinical Effects, and Therapeutic Potential of Cannabinoids for Gastrointestinal and Liver Diseases.
   Maselli DB, Camilleri M. · · 2021 · cited 20× · PMID 32673642 · DOI 10.1016/j.cgh.2020.04.020