CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients (CANPAIN)
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ClinicalTrials.gov Identifier: NCT05288010 |
Recruitment Status : Unknown
Verified March 2022 by Harley Street (CPC) Limited.
Recruitment status was: Enrolling by invitation
First Posted : March 18, 2022
Last Update Posted : March 18, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | February 22, 2022 | ||||
First Posted Date ICMJE | March 18, 2022 | ||||
Last Update Posted Date | March 18, 2022 | ||||
Estimated Study Start Date ICMJE | March 15, 2022 | ||||
Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients | ||||
Official Title ICMJE | CANPAIN Feasibility Study: Evaluating the Feasibility of Subsequently Undertaking a Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients | ||||
Brief Summary | The CANPAIN study has been devised to evaluate the efficacy and safety of a defined cannabis based medicinal product (CBMP) delivered by inhalation to patients with non cancer chronic pain attending a private clinic. CANPAIN is a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a cannabis based medicinal product (CBMP) for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management. CANPAIN will run for 3 years with a minimal planned sample size of 5000 participants per group who have completed at least 12 months of treatment. CANPAIN will be an MHRA and REC approved study. (See Appendix 1 of the Feasibility Study for the full draft protocol of the CANPAIN Study) Prior to commencing the CANPAIN study, the sponsor proposes to conduct a feasibility study. This study will aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics. |
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Detailed Description | The feasibility study will be based within a private clinic setting and will only involve existing patients of the clinic. The treatment regime, tests that the patients are required to take, the clinical information they are required to provide, and the informed consent required for treatment, will all follow the clinical protocol. The sponsor wishes to assess the feasibility of conducting the study within the private clinic to aid a future submission to Oxford A REC of the CANPAIN study. The feasibility study will be conducted over a 3-month period with a minimum target recruitment number of 100 patients. Feasibility will be assessed through 3 distinct domains: Recruitment and patient experience, medication logistics and data management. Patient experiences (part of domain 3) will be captured using comment forms, requesting feedback on ease of onboarding, ease of answering questionnaires, evidence of questionnaire fatigue and their satisfaction of service. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Treatment with cannabis via an inhalation device in addition to standard of care chronic pain treatment. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Chronic Pain | ||||
Intervention ICMJE | Combination Product: Cannabis
The provision of whole flower cannabis via an inhalation device in addition to standard of care chronic pain treatment.
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Study Arms ICMJE | Active Group
Patients of the clinic receiving cannabis treatment for non cancer chronic pain, who have been invited to join the study and have agreed and consented to join study.
Intervention: Combination Product: Cannabis
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 30, 2022 | ||||
Estimated Primary Completion Date | June 15, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05288010 | ||||
Other Study ID Numbers ICMJE | IRAS 304548 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Harley Street (CPC) Limited | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Harley Street (CPC) Limited | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Harley Street (CPC) Limited | ||||
Verification Date | March 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |