Is ZTL-106 effective in treating patients with chronic pain that resulted from a musculoskeletal injury?
- Conditions
- chronic non-cancer painmusculoskeletal injuryMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12622000120774
- Lead Sponsor
- evin Health Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 114
•Adult male and female age 25-75 years, inclusive.
•Confirmed incidence of average pain severity of equal to or greater than 4 on a numeric rating scale.
•Chronic pain for more than 6 months prior to screening that followed a knee or hip musculoskeletal injury.
•Participant agrees to abide by all study restrictions and comply with all study procedures.
•Participants must be informed of the investigational nature of this study and give written informed consent and agree to provide a contact phone number.
•Male participants must agree to an approved contraception method. This criterion must be followed from the time of the first dose of study medication until the last follow-up visit.
•Females of childbearing potential must have a negative pregnancy test at the Screening Visit and at the baseline visit prior to randomisation.
•Must not have used recreational medicinal cannabis for the last 30 days and agree to cease recreational medicinal cannabis during the study treatment and follow up period.
•Changes to current medications, or commencement of any new medications including prescription drugs (except hormonal contraception), vitamins, or herbal supplements within 28 days prior to the Screening Visit and during the study treatment phase. Daily administration of 100 mg aspirin will be allowed as long as the dose is stable for 30 days prior to Screening.
•Known history of cardiovascular disorders such as bradycardia, (<50 beats/min.) or tachycardia (>100 beats/min.), cardiac arrhythmia or a history of arrhythmias, myocardial infarction, stroke or signs or symptoms of unstable coronary artery disease within the last year.
•Poorly managed hypertension (systolic >160 mm Hg and/or diastolic >95 mm Hg) or hypotension (systolic <90 mm Hg and/or diastolic <60 mm Hg).
•Any medical condition that could account for the chronic pain (e.g., fibromyalgia) other than as a result of a previous musculoskeletal injury in the opinion of the clinical investigator.
•Recognised inflammatory condition (including rheumatoid arthritis, seronegative arthritis) that may influence the chronic pain in the opinion of the clinical investigator.
•Blood glucose, FBC, haemoglobin, platelets, creatinine, bilirubin, and AST/ALT outside the normal limits.
•Evidence of any clinically significant findings on Screening or baseline evaluations which, in the opinion of the clinical investigator would pose a safety risk or interfere with appropriate interpretation of study data.
•History of major psychiatric illness.
•History of drug or alcohol abuse within 1 year prior to screening as per investigator judgement or a positive alcohol or urine drug screen.
•Clinically significant infection (including bacterial, fungal or mycobacterial) within four weeks prior to screening.
•History of disorder that may necessitate the use of antibiotics during the study period.
•Positive serology for HIV, HBV or HCV.
•Receipt of any live attenuated vaccines within 4 weeks prior to entry.
•Any medical condition that in the judgement of the investigator will exclude the patient from participating in the study.
•Surgery within 3 months prior to screening.
•Known allergy to cannabinoids or related compounds.
•Planned participation in an investigational drug or device study; or has received an investigational biopharmaceutical product within 6 months prior to screening, or an investigational non-biopharmaceutical product or device within 30 days prior to screening.
•Required to operate heavy machinery for the duration of the study.
•Unable to refrain from driving for the duration of the study.
•Have a current compensable injury claim.
•If, in the opinion of the clinical investigator, the participant appears unable to perform the needed responsibilities of the clinical study.
•Females who are pregnant, breast feeding or planning a pregnancy; females of childbearing potential and male participants with a partner of childbearing potential, who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication.
oStandard acceptable methods include abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of daily administration of ZTL-106 medicinal cannabis product in patients with chronic pain after musculoskeletal injury.[Incidence and severity of adverse events, clinical laboratory tests as compared to baseline and/or the 4 week run in period and after the 6 weeks treatment window.];To evaluate the effect of daily administration of ZTL-106 medicinal cannabis product on pain interference with daily functions in patients with chronic pain after musculoskeletal injury.[Change in Brief Pain Inventory interference scale (BPI-I) scoring at week 4 and after 6 weeks as compared to baseline and/or the 4 week run in period]
- Secondary Outcome Measures
Name Time Method