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GI Medical Cannabis Study on IBD (GIMEDCAN)

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: NCT03886532
Recruitment Status : Withdrawn (Lack of funding/support)
First Posted : March 22, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:

Create a registry that will described the natural history and landscape of medical cannabis product use in patients with chronic abdominal pain or inflammatory bowel disease.

Quantitatively describe the pharmacokinetic (PK) profile of select medical cannabis products in patients with chronic neuropathic (abdominal) pain or inflammatory bowel disease.

To create an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.


Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Neuropathic Pain Other: Medical Marijuana

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: GI Medical Cannabis Registry and Pharmacology
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Group/Cohort Intervention/treatment
Medical Marijuana
Those subject taking only medical marijuana as standard of care. Will collect registry data and collect blood samples.
Other: Medical Marijuana
registry and blood samples

CBD only products
Those subjects taking only CBD products as standard of care. Will collect registry data and collect blood samples.
Other: Medical Marijuana
registry and blood samples




Primary Outcome Measures :
  1. Change in symptoms [ Time Frame: 1 year ]
    Relief of primary indication (perceived therapeutic benefit of product) reported via parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective.


Secondary Outcome Measures :
  1. Patient or caregiver reported side effects [ Time Frame: 1 year ]
    There is no particular scale or instrument being used to collect this data. Patients and caregivers are reporting on any perceived side effects from the medication.

  2. Changes in drug concentrations [ Time Frame: 1 year ]
    To assess changes in pharmacokinetic levels in the blood


Biospecimen Retention:   Samples Without DNA
We will consent subjects to retain microsampling samples.


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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are diagnosed with inflammatory bowel disease (IBD) and are taking medical marijuana or cannabidiol (CBD) legally
Criteria

Inclusion Criteria:

  1. Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of inflammatory bowel disease and chronic neuropathic (abdominal) pain.
  2. Individuals who have a diagnosis of Inflammatory Bowel Disease or chronic neuropathic (abdominal) pain.

Exclusion Criteria:

  1. Consumption of cannabis products that are not obtained from a state-sanctioned dispensary.
  2. Non English speaking individuals.

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): NCT03886532


Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Athena F Zuppa, MD MSCE Childrens Hospital of Philadelphia

Additional Information:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03886532     History of Changes
Other Study ID Numbers: 18-015221
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Neuralgia
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms