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Clinical Trial Details

Trial ID: L1132
Source ID: NCT05180968
Associated Drug: Nabilone 0.5 Mg Oral Capsule
Title: DIalysis Symptom COntrol-Pruritus Outcome Trial
Acronym: DISCO-POT
Status: COMPLETED
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Pruritus
Interventions: DRUG: Nabilone 0.5 MG Oral Capsule|DRUG: Placebo Nabilone
Outcome Measures: Primary: Change from baseline in worst uremic pruritis severity rating between treatment arms relative to MID, Measured using Visual Analogue Scale (VAS), Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10 | Secondary: Number of participants with safety outcomes including adverse events related to study drug, serious adverse events, adverse events leading to drug discontinuation, hospitalization or emergency room visit for altered level of consciousness, fall, fracture, death, symptomatic hypotension requiring an intervention, Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10,11|Change in uremic pruritis severity, Measured as change from baseline in mean Visual Analogue Scale (VAS), Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10|Change in uremic pruritis severity, Measured as change from baseline in mean Verbal Rating Scale (VRS), Measured at study baseline and weeks 1,2,3,4,5,6,7,8,9,10|Change in health-related quality of life, Measured using the Dermatology Quality of Life Index (DLQI), Measured at study baseline and weeks 3 and 4 of each crossover|Change in health-related quality of life, Measured using the EQ-5D 5 Level (EQ-5D-5L), Measured at study baseline and weeks 3 and 4 of each crossover|Change in health-related quality of life, Measured using the Patient Global Impression (PGI), Measured at study baseline and weeks 3 and 4 of each crossover|Effect of nabilone on sleep quality, Measured using the Pittsburgh Sleep Quality Index (PSQI), Measured at study baseline and weeks 3 and 4 of each crossover
Sponsor/Collaborators: Sponsor: University of Manitoba | Collaborators: Population Health Research Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-08-02
Completion Date: 2023-08-11
Results First Posted:
Last Update Posted: 2023-11-30
Locations: University of Alberta Hospital, Edmonton, Alberta, T6G2P4, Canada|Seven Oaks General Hospital, Winnipeg, Manitoba, R2V 3M3, Canada
URL: https://clinicaltrials.gov/show/NCT05180968