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Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain

NCT02569073 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-09-26

No results posted yet for this study

Summary

In a recent study, Dronabinol was shown to reduce symptoms in patients with Functional Chest Pain (non-cardiac chest pain). Additionally, metabolic measures and patients' weights were not adversely affected by this regiment. In fact, some cholesterol measures trended in a favorable direction with Dronabinol. The study lasted 28 days and patients took Dronabinol twice daily. The goal of this current study focuses on reducing the dose of Dronabinol to see if the same goals can be achieved. More so, the study will be extended to 12 weeks to gain a more longitudinal picture of therapy with Dronabinol. It is hypothesized that reducing the dose and extending the duration will continue to show an improvement in symptoms as well as no adverse metabolic outcomes.

Conditions

  • Esophageal Diseases

Interventions

DRUG

Dronabinol

Dronabinol 5 mg, every other night, orally

DRUG

Placebo

Placebo--no drug

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Ron W Schey, M.D. · Temple University

  • Zachary W Reichenbach, M.D., Ph.D. · Temple University

  • Henry Parkman, M.D. · Temple University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2019-08-01
Completion
2019-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02569073 on ClinicalTrials.gov