Cannabinor is as an analgesic and anti-inflammatory agent. By its nature, it has been designed to be more active at the CB2 peripheral receptors and have less activity at the central CB1 receptors. Thus, by design, cannabinor is expected to have less psychotropic effect than natural cannabinoids, such as those found in cannabis (including THC). MedDRA version: 8.1 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
Product Name: Cannabinor
Pharmaceutical Form: Solution for infusion
Current Sponsor code: PRS 211,375
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Pharmos Corp.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: a. Males 18 to 55 years of age; b. Patients scheduled to undergo surgical extraction of one or two ipsilateral impacted third molars, at least one of which must be at least a partial bony mandibular extraction; c. Use of only the following pre-operative medication(s)/ anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) without a vasoconstrictor; d. Able to read, comprehend, and sign the consent form; e. Examined by the attending dentist and physician and medically cleared to participate in the study; f. In good general health with no contraindications to any of the study or rescue medications. g. Normal ECG with baseline QTcF =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Presence of a serious medical condition (e.g., hypertension, poorly controlled diabetes, impaired cardiac, hyper- or hypothyroidism); b. Baseline QTcF>450 msec as measured in the screening ECG or family history of Long QT syndrome; c. Impaired renal or hepatic function as measured in the clinical safety laboratory test results in the screening visit; d. Presence of orthostatic hypotension upon screening. e. Need for continuous medical treatment within two weeks prior to study entry with the exception of L-thyroxin for continuous treatment of a hypothyreosis; f. Acute local infection at the time of surgery that could confound the post-surgical evaluation; g. Known CNS disturbance or history of seizure disorder; h. History of alcoholism or substance abuse or daily consumption of 5 or more alcohol-containing beverages; i. Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week for other but impacted wisdom tooth pain); j. Prior use of any prescription or nonprescription drug including analgesics such as NSAID (including aspirin, sedative, or CNS/ psychotropic) within 5 days of the surgical procedure, except for paracetamol and ibuprofen which can be used up to 2 days prior to the surgical procedure and pre-anesthetic medication and anesthesia for the procedure; k. Has ingested any caffeine-containing beverages, chocolate, or alcohol 4 hours or less before taking study medication; l. Has been treated for depression within the past 6 months; m. Has a family history of any psychiatric disorder or current psychiatric disorder. n. Has taken an investigational drug within the past 30 days; o. Can not refrain from smoking 4 hours before and during the duration of the stay at the investigational site; p. History of allergy to any cannabinoid-like product; q. Has previously been entered into this study; r. Study site or Sponsor employee or relative of an employee who is directly involved in the study. s. Unable to return for follow-up or comply with other study requirements in the opinion of the investigator. t. Seropositive for HIV antibodies HIV1 and HIV2, hepatitis B surface antigen (HBs-Ag) and hepatitis C antibody (Hep C Ab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the present study is to evaluate the analgesic efficacy of three dosages of cannabinor compared to placebo over 8 hours using the dental impaction acute pain model. The objectives of the present study are to evaluate the efficacy and safety of three dosages of cannabinor compared to placebo in an 8-hour study of dental pain following extraction of one mandibular or two ipsilateral impacted or partly impacted third molars. Following the surgical procedure, the efficacy of a single administration of any one of three doses of cannabinor or that of placebo will be evaluated. In case Pharmos decides to conduct an interim analysis based on the blinded data from the first 40 subjects, evaluation of two different dosages (instead of three) of cannabinor compared to placebo will be performed. ;Secondary Objective: None.; Primary end point(s): • TOTPAR 8: time weighted sum of Pain Relief Rating (PRR) scores over 8 hours; and • Duration of relief as measured by the time to rescue medication | — |
Countries
United Kingdom
Outcome results
None listed