Trial · NCT04601207
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the curve (AUC0-48h) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Area under the curve (AUC0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Primary | Maximum concentration (Cmax, 0-48h) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Maximum concentration (Cmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Primary | Time to maximum concentration (Tmax) | 48 hours (Time points assessed for AUC0-48 h: pre-dose and post-dose at 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 and 48 hours) | Time to maximum concentration (Tmax, 0-48h) for CBD, Δ9-THC, 11-OH-THC and 11-NOR-9-CARBOXY-Δ9-THC in plasma after the administration of the investigational product or active comparator product. |
| Secondary | Urine CBD concentration | 48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose) | CBD concentrations in urine after the acute administration of the investigational product and the active comparator product |
| Secondary | Urine Δ9-THC concentration | 48 hours (Time points assessed are:0 (pre-dose), 0-4, 4-8, 8-12 hours, 12-24 hours and 24-48 hours post-dose) | Δ9-THC concentrations in urine after the acute administration of the investigational product and the active comparator product |
| Secondary | Cognitive function | 48 hours | Assessment of cognitive functions by BrainCheck questionnaire for the investigational product and active comparator product. It involves tests of memory (immediate- and delayed-recall) and of cognitive processing and executive function (digit-symbol substitution, trail-making, Stroop Interference). Once a patient has completed the assessments, the BrainCheck platform immediately provides validated, norm-based scores to the investigators. These scores are adjusted for age, derived from a normative database ranging from ages 10 to 99. Raw scores for the different parameters are scaled and ranked in percentiles. Scores that fall within a range of one standard deviation above the mean (50th percentile) indicate "normal" cognitive function. So, overall scores above 50th percentile are graded normal cognitive function while those below 50th suggest cognitive impairment. |
| Secondary | Subjective evaluation of drug effects | 48 hours | This is done using the Drug-effect questionnaire (DEQ-5) which is a 5-question questionnaire evaluating the effects of the study product. The Five questions assess drug effects, perception and likability. The number and percentage of subjects per response will be presented for each time point according to treatment. Differences between groups will be assessed using a generalized linear mixed model assuming an ordinal response with treatment, time points and treatment by time points as fixed effects and subject as random effect.Outcomes will be summarized using descriptive statistics. |
| Other | Pre-emergent and post-emergent adverse events | 72 hours | The incidence of pre-emergent and post-emergent adverse events following a single dose of the investigational product and the comparator product. Adverse events are recorded in the study diary. |
| Other | Blood pressure | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on systolic and diastolic blood pressure |
| Other | Heart rate | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on heart rate |
| Other | Alanine aminotransferase (ALT) | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on alanine aminotransferase (ALT) |
| Other | Aspartate aminotransferase (AST) | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on aspartate aminotransferase (AST) |
| Other | Bilirubin | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on bilirubin |
| Other | Creatinine | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on creatinine |
| Other | Sodium ion | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on sodium ion |
| Other | Potassium ion | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on potassium ion |
| Other | Chloride ion | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on chloride ion |
| Other | Calcium ion | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on calcium ion |
| Other | Estimated glomerular filtration rate (eGFR) | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on estimated glomerular filtration rate (eGFR) |
| Other | White blood cell count | 48 hours post dose | The effect of a single dose of the investigational product and the comparator product on white blood cell count |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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