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Trial record 2 of 8 for:    pure green

Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193631
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Pure Green

Brief Summary:
The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Drug: Cannabidiol (CBD) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain
Actual Study Start Date : December 7, 2019
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 9, 2019

Arm Intervention/treatment
Experimental: Pure Green Tablet
A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD).
Drug: Cannabidiol (CBD)
A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.




Primary Outcome Measures :
  1. Impact of Pure Cannabidiol (CBD) tablets on safety in patient's with musculoskeletal pain using a self-reported pain scale score. [ Time Frame: 1 Day ]
    To evaluate the safety and efficacy of Pure Green Cannabidiol (CBD) sublingual tablets for the treatment of musculoskeletal pain by having patients evaluate their Numeric Pain Rating Scale (NPRS) score reported as 0-10 where 0 is no pain and 10 is the worst pain possible.


Secondary Outcome Measures :
  1. To evaluate efficacy of a low dose of Cannabidiol (CBD) in the treatment of mild to moderate musculoskeletal pain. [ Time Frame: 1 Day ]
    To explore the impact of Pure Green sublingual tablets on patient self-reported Numeric Pain Rating Scale (NPRS), as a route of administration and reduction in baseline pain scores.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female at least 21 years of age;
  2. Subject has mild to moderate musculoskeletal pain;
  3. Pain for greater than or equal to 10 days of each month for 3 months prior to study entry for which the pain requires treatment.
  4. Has an Numeric Pain Rating Scale (NPRS) score of 3 or greater,
  5. If female, subject is practicing an approved method of birth control throughout the study;
  6. Subject is willing and able to comply with all protocol-specified requirements;
  7. Subject is willing to take Pure Green tablets only and will not take any other pain medications,
  8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
  9. Subject is willing to document pain scale scores in a diary.

Exclusion Criteria:

  1. Subject has any condition for which the investigator does not feel the participant should be enrolled due to possible safety or compliance issues;
  2. Subject has received treatment with an investigational drug or therapy within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
  3. Subject has a known allergy to active or inert ingredients of Pure Green tablets;
  4. Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis (marijuana) or any cannabinoid products including Cannabidiol (CBD) or Tetrahydrocannabinol (THC); Any drug or herbal product that influences the endocannabinoid system (ECS));
  5. Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
  6. Have a history of recurrent seizures other than febrile seizures.
  7. Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
  8. Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
  9. Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain.
  10. Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
  11. Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193631


Locations
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United States, Pennsylvania
Dr. Kimless' Clinic
Chadds Ford, Pennsylvania, United States, 19317
Sponsors and Collaborators
Pure Green
Investigators
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Principal Investigator: Debra Kimless, MD Chief Medical Officer

Publications:
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Responsible Party: Pure Green
ClinicalTrials.gov Identifier: NCT04193631    
Other Study ID Numbers: PG-19-00A
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pure Green:
CBD
Cannabidiol
Musculoskeletal Pain
Pain
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Epidiolex
Anticonvulsants