---
title: Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia
nct_id: NCT03941288
overall_status: COMPLETED
phase: PHASE2
sponsor: Mayo Clinic
study_type: INTERVENTIONAL
primary_condition: Gastroparesis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03941288.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03941288"
ct_last_update_post_date: 2024-02-13
last_seen_at: "2026-05-12T07:01:24.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

**Official Title:** Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

**NCT ID:** [NCT03941288](https://clinicaltrials.gov/study/NCT03941288)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 92
- **Lead Sponsor:** Mayo Clinic
- **Collaborators:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Gastroparesis, Dyspepsia
- **Start Date:** 2019-09-04
- **Completion Date:** 2023-02-23
- **CT.gov Last Update:** 2024-02-13

## Brief Summary

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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with gastroparesis or functional dyspepsia (FD)
* Age 18-70 years
* Patients will be identified from among Mayo Clinic patients.
* Patients will have symptoms consistent with gastroparesis based on a national guideline for gastroparesis (symptoms plus delayed gastric emptying of solids). Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:

  * Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis:
  * One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning
  * Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal)
  * No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations.
  * Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
* Ability to provide informed consent
* Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
* Body mass index of 18-35 kg/m2
* Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are

Exclusion Criteria:

* Patients with current H. pylori infection will be excluded.
* Pregnancy or lactation
* Rapid metabolizers for CYP3A4 or CYP2C19 \[estimated prevalence of 17% and 18% respectively
* based on literature review will be excluded since this could impact assessment of effects of cannabidiol
* Patients with abnormal baseline liver transaminases (any value above UNL), since up to 3-fold, dose-related elevations of liver transaminases (ALT and/or AST) occur in 13% of treated patients (vs. 1% placebo);
* Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX
* Concomitant use of valproate, central nervous system (CNS) depressants and alcohol, other hepatotoxic drugs
```

## Arms

- **Pharmacodynamics and clinical effects of cannabidiol** (ACTIVE_COMPARATOR) — 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.
- **pharmacodynamics and clinical effects of placebo** (PLACEBO_COMPARATOR) — 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.

## Interventions

- **Cannabidiol** (DRUG) — 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.

In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.
- **placebo** (OTHER) — 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.

In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued.

## Primary Outcomes

- **Gastric Emptying Half-time (T1/2) of Solids** _(time frame: 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.
- **Gastric Emptying Lag Time (T-lag) of Solids** _(time frame: 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.
- **Fasting Gastric Volume** _(time frame: 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).
- **Gastric Accommodation** _(time frame: 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).
- **Satiation Volume to Fullness** _(time frame: 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.
- **Satiation Maximum Tolerated Volume (MTV)** _(time frame: 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 Outcomes

- **Weekly Global Symptom Assessment** _(time frame: 4 weeks)_
- **Mean Daily Symptom Score in Functional Dyspepsia** _(time frame: 4 weeks)_
- **Mean Daily Epigastric Pain in Functional Dyspepsia** _(time frame: 4 weeks)_
- **Quality of Life in Functional Dyspepsia** _(time frame: 4 weeks)_
- **Aggregate Symptom Score** _(time frame: 4 weeks)_
- **Overall Severity in Gastroparesis** _(time frame: 4 weeks)_
- **Average Daily Vomiting Episodes in Gastroparesis** _(time frame: 4 weeks)_

## Locations (1)

- Mayo Clinic in Rochester, Rochester, Minnesota, United States

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic in rochester|rochester|minnesota|united states` — added _(2026-05-12)_

---

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