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NCT03886753 · ClinicalTrials.gov registry record
Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products
A clinical trial, sponsored by Children's Hospital of Philadelphia.
- Terminated
- Registry status
- 10
- Enrollment target
NCT03886753: Clinical Trial study, sponsored by Children's Hospital of Philadelphia.
NCT03886753 is a clinical trial that was terminated before completion, run by Children's Hospital of Philadelphia. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03886753 was terminated before completion, sponsored by Children's Hospital of Philadelphia.
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.
Primary Outcome
Relief of primary indication (perceived therapeutic benefit of product)as reported by parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective
Interventions
- OTHER Registry
- OTHER PK microsampling of blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-05-15 |
| Est. Completion | 2020-06-30 |
Why NCT03886753 stopped before completion
NCT03886753 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Registry is the first listed.
NCT03886753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03886753 about?
NCT03886753 is a clinical study titled "Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products". This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease)...
What is the current status of trial NCT03886753?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2019-05-15. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03886753?
The interventions under investigation include: Registry (OTHER), PK microsampling of blood (OTHER).
Who is sponsoring clinical trial NCT03886753?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
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