Optic

ID

Name

19-002483

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).

Trial arms

Trial start

2019-09-04

Estimated PCD

2023-02-23

Trial end

2023-02-23

Status

Completed

Phase

Early phase I

Treatment

Cannabidiol

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.

Arms:

Pharmacodynamics and clinical effects of cannabidiol

placebo

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.

Arms:

pharmacodynamics and clinical effects of placebo

Size

92

Primary endpoint

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

4 weeks

Gastric Emptying Lag Time (T-lag) of Solids

4 weeks

Fasting Gastric Volume

4 weeks

Gastric Accommodation

4 weeks

Satiation Volume to Fullness

4 weeks

Satiation Maximum Tolerated Volume (MTV)

4 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

Updated at

2024-02-13

Organization

Drug

Indication

Indication

Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia