Esophageal DiseasesPhase 4ICAMPNCT02569073

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

A Phase 4 study testing Dronabinol in people with Esophageal Diseases, run by Temple University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Esophageal Diseases
What is being tested?: Dronabinol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2017to 1 Sep 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least one episode of chest pain a week in the past month. Previous negative cardiac evaluation (EKG ± non invasive stress test ± coronary angiogram). Negative esophageal evaluation for a motility disorder (eg: achalasia) and GERD (normal endoscopy, normal 24 hr pH study, or unresponsive to 6 weeks of BID PPI therapy)

Who cannot join

Subjects requiring narcotics or other pain medications,
Subjects with known GERD (unless responsive to PPI therapy and on a stable dose), esophagitis, Barrett's esophagus or peptic stricture on endoscopy
Subjects with previous upper gastrointestinal surgery
Pregnancy
Subjects with diabetes, neuromuscular disorders, cardiac disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic).
Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)

Show all 10Show fewer

Medications such as baclofen, sucralfate and prokinetic agents or any agent considered a sedative, hypnotic, or psychoactive drug.
Known history of substance abuse.
Subject unable to consent.
Patient has history of comorbid psychiatric conditions including mania and schizophrenia. Patients will also be excluded who currently have a diagnosis of depression or undergoing treatment for depression.

Trial locations and contacts

1 site in 1 country.

United States1 site

Temple University Hospital
Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

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.

Read the detailed description

About 200,000 new cases of Functional Chest Pain (FCP) are diagnosed annually in USA. FCP is associated with poor quality of life and high health care expenditure. Gastroesophageal reflux disease (GERD), esophageal motility disorders, and psychological disorders may cause FCP. However, the mechanism(s) for FCP continue to be explored and include central and peripheral hypersensitivity as well as biomechanical dysfunction of the esophageal wall. CB1 receptor activation in synaptic clefts fine tunes neuronal firing and may in fact quell the over excitation associated with hypersensitivity.

Dronabinol, a cannabinoid receptor agonist with a preference for CB1 over CB2, is believed to reduce the esophageal hypersensitivity. CB1 receptors are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. Activation of pre-junctional CB1 receptors may reduce excitatory enteric transmission and conceivably improve esophageal hyperreactivity and hypersensitivity, the hallmarks of FCP.

Previously, it was shown that Chest Pain Symptoms were greatly reduced when patients took 5 mg Dronabinol twice daily. Patients had very few side effects from this regiment although sedation was reported. The goal of this study focuses on reducing the dose of Dronabinol to 5 mg every other day, or essentially, one quarter of the dose. The effect of Dronabinol varies with CB1 receptor density in various tissues. It is hypothesized that at this reduced dose relief of chest pain will still be achieved without the sedating effects.

More so, Dronabinol at 5 mg twice daily failed to produce any adverse metabolic outcomes including measures of glucose, LDL, triglycerides, leptin, or transaminases. Dronabinol treatment tended to improve some of these measures although the study only lasted 28 days. Currently the hypothesis is that lower doses at a protracted time course will again fail to perturb homeostasis.

Conditions: Esophageal Diseases
Being tested: Dronabinol, Placebo
Keywords: Functional Chest Pain, Non-Cardiac Chest Pain, Esophageal Hypersensitivity
Medical subject headings: Esophageal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DronabinolDrug
Also called Marinol
Dronabinol 5 mg, every other night, orally
PlaceboDrug
Placebo--no drug

Study groups in NCT02569073
Study group	Role	What they receive
Dronabinol	Experimental	Patients who receive Dronabinol 5 mg, every other night, orally. Receives: Drug: Dronabinol
Placebo	Placebo comparator	Patients who receive Placebo every other night, orally Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Chest Pain
Patient will fill out a Chest Pain Questionnaire and symptom diary daily of symptoms which will be normalized to a numerical value for comparison among groups.
Measured: Daily assessment for 12 weeks

Secondary outcomes (19)

Chest Pain Intensity
Patient will fill out a Chest Pain Questionnaire and symptom diary daily of symptoms which will be normalized to a numerical value for comparison among groups.
Measured: Daily assessment for 12 weeks
GERD Symptom Checklist
Patients will fill out a questionnaire pertaining to GERD symptoms which will be normalized to a numerical value for comparison among groups.
Measured: Baseline, 2, 4, 8, and 12 weeks
Short Form 36
A general health-related quality of life questionnaire that examines 8 domains: Physical Functioning, Role Functioning Physical, Role Functioning Emotional, Mental Health, Vitality, Bodily Pain, General Health, and Social Functioning
Measured: Baseline, 2, 4, 8, and 12 weeks
Esophageal Hypersensitivity and Distention
Sensory thresholds for first sensation, discomfort, and pain in the esophagus. Frequency, amplitude, area under the curve (AUC) of reactive esophageal contractions
Measured: Baseline, 4, 8, and 12 weeks
Beck Depression Index
Analysis of depressive symptoms normalized to a numerical value for comparison among groups.
Measured: Baseline, 2, 4, 8, and 12 weeks
Metabolic Parameters
Total cholesterol will be measured and reported in mg/dL.
Measured: Baseline, 2, 4, 8, and 12 weeks
Weight
Patient mass will be measured in kg.
Measured: Baseline, 2, 4, 8, and 12 weeks
Beck Anxiety Index
Analysis of anxious symptoms normalized to a numerical value for comparison among groups.
Measured: Baseline, 2, 4, 8, and 12 weeks
Waist Circumference
Patient's waist in cm will be measured.
Measured: Baseline, 2, 4, 8, and 12 weeks
Non-HDL Cholesterol
Non-HDL cholesterol will be measured and reported in mg/dL.
Measured: Baseline, 2, 4, 8, and 12 weeks
HDL Cholesterol
HDL cholesterol will be measured and reported in mg/dL.
Measured: Baseline, 2, 4, 8, and 12 weeks
Triglycerides
Triglycerides will be measured and reported in mg/dL.
Measured: Baseline, 2, 4, 8, and 12 weeks
Glucose
Glucose will be measured and reported in mg/dL.
Measured: Baseline, 2, 4, 8, and 12 weeks
Insulin
Insulin will be measured and reported in µU/mL.
Measured: Baseline, 2, 4, 8, and 12 weeks
Leptin
Leptin will be measured and reported in ng/mL.
Measured: Baseline, 2, 4, 8, and 12 weeks
ALT
Leptin will be measured and reported in IU/L.
Measured: Baseline, 2, 4, 8, and 12 weeks
AST
Leptin will be measured and reported in IU/L.
Measured: Baseline, 2, 4, 8, and 12 weeks
LDH
LDH will be measured and reported in IU/L.
Measured: Baseline, 2, 4, 8, and 12 weeks
CRP
CRP will be measured and reported in mg/L.
Measured: Baseline, 2, 4, 8, and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 20171 Sep 2019

First posted6 Oct 2015 (estimated)
Study start21 Jun 2017
Primary completion1 Aug 2019
Study completion1 Sep 2019

Why it stopped: Funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Esophageal DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02569073
Sponsor's protocol ID: 22894
Acronym: ICAMP
Status last verified: Sep 2019
First submitted: 30 Sep 2015
Last updated: 26 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
ClinicalTrials.gov ID: NCT02569073
Acronym / sponsor ID: ICAMP / 22894
Conditions: Esophageal Diseases
Keywords: Functional Chest Pain, Non-Cardiac Chest Pain, Esophageal Hypersensitivity
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Funding
Enrolment: 0 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Study start: 21 Jun 2017 (actual)
Primary completion: 1 Aug 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 6 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Dronabinol	Experimental	Drug: DronabinolPatients who receive Dronabinol 5 mg, every other night, orally.
Placebo	Placebo comparator	Drug: PlaceboPatients who receive Placebo every other night, orally

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

At least one episode of chest pain a week in the past month. Previous negative cardiac evaluation (EKG ± non invasive stress test ± coronary angiogram). Negative esophageal evaluation for a motility disorder (eg: achalasia) and GERD (normal endoscopy, normal 24 hr pH study, or unresponsive to 6 weeks of BID PPI therapy)

Key exclusion criteria (10 listed)

Subjects requiring narcotics or other pain medications,
Subjects with known GERD (unless responsive to PPI therapy and on a stable dose), esophagitis, Barrett's esophagus or peptic stricture on endoscopy
Subjects with previous upper gastrointestinal surgery
Pregnancy
Subjects with diabetes, neuromuscular disorders, cardiac disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DronabinolAlso: MarinolDronabinol 5 mg, every other night, orally	Drug	Dronabinol
PlaceboPlacebo--no drug	Drug	Placebo

Primary outcome

Chest Pain
Time frame: Daily assessment for 12 weeks
Patient will fill out a Chest Pain Questionnaire and symptom diary daily of symptoms which will be normalized to a numerical value for comparison among groups.

19 secondary outcomes

Chest Pain Intensity
Time frame: Daily assessment for 12 weeks
GERD Symptom Checklist
Time frame: Baseline, 2, 4, 8, and 12 weeks
Short Form 36
Time frame: Baseline, 2, 4, 8, and 12 weeks
Esophageal Hypersensitivity and Distention
Time frame: Baseline, 4, 8, and 12 weeks
Beck Depression Index
Time frame: Baseline, 2, 4, 8, and 12 weeks
Metabolic Parameters
Time frame: Baseline, 2, 4, 8, and 12 weeks
Weight
Time frame: Baseline, 2, 4, 8, and 12 weeks
Beck Anxiety Index
Time frame: Baseline, 2, 4, 8, and 12 weeks
Waist Circumference
Time frame: Baseline, 2, 4, 8, and 12 weeks
Non-HDL Cholesterol
Time frame: Baseline, 2, 4, 8, and 12 weeks
HDL Cholesterol
Time frame: Baseline, 2, 4, 8, and 12 weeks
Triglycerides
Time frame: Baseline, 2, 4, 8, and 12 weeks
Glucose
Time frame: Baseline, 2, 4, 8, and 12 weeks
Insulin
Time frame: Baseline, 2, 4, 8, and 12 weeks
Leptin
Time frame: Baseline, 2, 4, 8, and 12 weeks
ALT
Time frame: Baseline, 2, 4, 8, and 12 weeks
AST
Time frame: Baseline, 2, 4, 8, and 12 weeks
LDH
Time frame: Baseline, 2, 4, 8, and 12 weeks
CRP
Time frame: Baseline, 2, 4, 8, and 12 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
Individual participant dataSharing planned: No

Related trials for Esophageal Diseases

RecruitingPhase 2/3
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RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ron W Schey, M.D. principal investigator

Temple University

Zachary W Reichenbach, M.D., Ph.D. principal investigator

Temple University

Henry Parkman, M.D. principal investigator

Temple University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dronabinol in people with Esophageal Diseases, run by Temple University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest Pain (time frame: Daily assessment for 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02569073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.