Chest PainPhase 4NCT01598207
The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
A Phase 4 study testing Marinol in people with Chest Pain, run by Yehudith Assouline-Dayan at 1 site in United States.
Trial summary
Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is associated with poor quality of life and high health care expenditure of 8 Billion Dollars a year. Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological issues may cause NCCP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Marinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or Female
- Ages 18-75 years
- Non-GERD related Non cardiac chest pain (Evaluated previously with an EGD, Esophageal manometry, and 24 Hour ambulatory pH study)
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± Non invasive stress test ± Coronary angiogram)
Who cannot join
- Subjects requiring narcotics or other pain medications
- Subjects with known esophagitis, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with Diabetes, neuromuscular disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric)
- Subjects with upper airway symptoms (such as hoarseness, wheezing or laryngospasm)
Show all 9Show fewer
- Medications such as baclofen, H2 blockers, PPI, sucralfate and prokinetics.
- Known history of substance abuse
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is associated with poor quality of life and high health care expenditure of 8 Billion Dollars a year.
Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological issues may cause NCCP.
Read more
The mechanism(s) for pain continue to be explored and include central and peripheral hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone, or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly there is a large unmet therapeutic need.
Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main component of Cannabis acts through specific receptors, that are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks of NCCP.
STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom diary and impedance planimetry. The primary outcome measure will be the frequency of chest pain episodes. Secondary outcome measures include improvement in esophageal sensory thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and global improvement of symptoms.
HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in NCCP patients, when compared to placebo.
AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of action.
- Conditions
- Chest Pain
- Being tested
- Marinol, Placebo
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarinolDrug
5mg BID, orally for 1 month
PlaceboDrug
5mg BID, orally for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Marinol | Experimental | Not described Receives: Drug: Marinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Chest Pain Episodes
Number of people still experiencing the same amount of chest pain during treatment than previously without
Measured: Baseline and 1 month
Secondary outcomes (6)
Frequency of Chest Pain in Treatment Group vs Baseline
Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration
Measured: 1 month
Intensity of Chest Pain Episodes
Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged
Measured: Baseline and 1 month
Sensory Thresholds for First Sensation
This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg
Measured: Baseline and 1 month
Duration of Chest Pain Episodes
0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged
Measured: Baseline vs 1 month
Sensory Thresholds for Discomfort
When participants felt pain at earliest pressure; range 0-65 mmHg
Measured: Baseline and 1 month
Sensory Thresholds for Pain
When highest amount of pain was felt; range is 0-65 mmHg
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startFeb 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yehudith Assouline-Dayan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yehudith Assouline-Dayan, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598207
- Sponsor's protocol ID
- 201003768
- Status last verified
- Apr 2017
- First submitted
- 10 May 2012
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Reichenbach ZW, Sloan J, Rizvi-Toner A, Bayman L, Valestin J, Schey R. A 4-week pilot study with the cannabinoid receptor agonist dronabinol and its effect on metabolic parameters in a randomized trial. Clin Ther. 2015 Oct 1;37(10):2267-74. doi: 10.1016/j.clinthera.2015.07.023. Epub 2015 Aug 14.
PubMed 26283236
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain
- ClinicalTrials.gov ID
- NCT01598207
- Acronym / sponsor ID
- 201003768
- Conditions
- Chest Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yehudith Assouline-DayanUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Noncardiac chest pain (NCCP) affects 200,000 new cases annually in USA. It is associated with poor quality of life and high health care expenditure of 8 Billion Dollars a year.
Gastroesophageal Reflux Disease(GERD), esophageal motility disorders, and psychological issues may cause NCCP.
The mechanism(s) for pain continue to be explored and include central and peripheral hypersensitivity, and mechanophysical abnormalities. Treatment of NCCP has focused on relieving visceral hypersensitivity through pain modulators, such as tricyclics, trazodone, or adenosine receptor antagonist, theophylline. Typically, only 40-50 % respond and clearly there is a large unmet therapeutic need.
Cannabis is felt to be beneficial for vomiting, diarrhea and intestinal pain. The main component of Cannabis acts through specific receptors, that are located primarily on central and peripheral neurons (including the enteric nervous system) and myenteric plexus where they modulate neurotransmitter release. Activation of these receptors reduces excitatory enteric transmission and may improve esophageal hyperreactivity and hypersensitivity, the hallmarks of NCCP.
STUDY PROTOCOL: The investigators will randomize 40 subjects with non-cardiac, non-reflux chest pain to receive dronabinol (5 mg Bid), or placebo for 4 weeks. Chest pain symptoms and esophageal sensorimotor properties will be assessed at baseline and at 4 weeks using symptom diary and impedance planimetry. The primary outcome measure will be the frequency of chest pain episodes. Secondary outcome measures include improvement in esophageal sensory thresholds, reduced reactive contractions, frequency, amplitude, area under the curve, and global improvement of symptoms.
HYPOTHESIS: Cannabinoids decrease esophageal hypersensitivity and ameliorate chest pain in NCCP patients, when compared to placebo.
AIM: To perform a randomized double blind study to investigate the effects of Dronabinol, a CB1 and CB2 agonist, in the treatment of patients with NCCP and examine its mechanism of action.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marinol | Experimental | Drug: Marinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Ages 18-75 years
- Non-GERD related Non cardiac chest pain (Evaluated previously with an EGD, Esophageal manometry, and 24 Hour ambulatory pH study)
- At least one episode of chest pain a week in the past month
- Previous negative cardiac evaluation (EKG ± Non invasive stress test ± Coronary angiogram)
Key exclusion criteria (9 listed)
- Subjects requiring narcotics or other pain medications
- Subjects with known esophagitis, Barrett's esophagus or peptic stricture on endoscopy
- Subjects with previous upper gastrointestinal surgery
- Pregnancy
- Subjects with Diabetes, neuromuscular disorders, or other severe co-morbidities (Cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic, and psychiatric)
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 |
|---|---|---|
| Marinol5mg BID, orally for 1 month | Drug | Marinol |
| Placebo5mg BID, orally for 1 month | Drug | Placebo |
Primary outcome
Frequency of Chest Pain Episodes
Time frame: Baseline and 1 month
Number of people still experiencing the same amount of chest pain during treatment than previously without
6 secondary outcomes
Frequency of Chest Pain in Treatment Group vs Baseline
Time frame: 1 month
Intensity of Chest Pain Episodes
Time frame: Baseline and 1 month
Sensory Thresholds for First Sensation
Time frame: Baseline and 1 month
Duration of Chest Pain Episodes
Time frame: Baseline vs 1 month
Sensory Thresholds for Discomfort
Time frame: Baseline and 1 month
Sensory Thresholds for Pain
Time frame: Baseline and 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26283236Reichenbach ZW, Sloan J, Rizvi-Toner A, Bayman L, Valestin J, Schey R. A 4-week pilot study with the cannabinoid receptor agonist dronabinol and its effect on metabolic parameters in a randomized trial. Clin Ther. 2015 Oct 1;37(10):2267-74. doi: 10.1016/j.clinthera.2015.07.023. Epub 2015 Aug 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Marinol in people with Chest Pain, run by Yehudith Assouline-Dayan 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Chest Pain Episodes (time frame: Baseline and 1 month). 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 NCT01598207, which also lists 1 linked publication.
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 28 Apr 2017.