Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05180968
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2021-11-24
Brief Title:
DIalysis Symptom COntrol-Pruritus Outcome Trial
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Dialysis Symptom Control-Pruritus Outcome Trial A Randomized Blinded Placebo Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCO-POT
Brief Summary:
The purpose of this study is to test whether or not a medication called nabilone which is a synthetic non-natural medication derived from cannabis compared to placebo improves symptoms of itch in hemodialysis as measured by visual analog scales
Detailed Description:
Several different types of medications are effective in treating uremic pruritus but even with effective treatments residual symptoms are common and some medications are not well tolerated Standard of care treatments include emollients which are lotions that keep the skin hydrated and a variety of pills that target the itch pathways implicated in the disease
The objective of the study is to determine the proportion of patients with kidney failure for whom oral nabilone provides important benefit in reducing uremic pruritis without important adverse effects The hypothesis is that there is a substantial proportion of patients in whom oral nabilone are safe and effective beyond placebo effects
Nabilone is currently used to treat conditions other that uremic pruritus including chronic nerve pain as well as nausea and vomiting due to chemotherapy It has never been studied in the setting of kidney disease
DISCO-POT is a blinded placebo-controlled crossover trial in which participants will be followed for 11 weeks including two 4 week treatment crossover periods with a 2 week washout period in between them and an end of study visit after 1 week off study drugs
Patients that are eligible will be randomly assigned to a crossover treatment sequence of two treatments
1 nabilone 05 mg orally at night for 1 week increased to nabilone 05mg orally twice a day for 3 weeks over-encapsulated
2 placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks over-encapsulated
The objective of the study is to determine the proportion of patients with kidney failure for whom oral nabilone provides important benefit in reducing uremic pruritis without important adverse effects The hypothesis is that there is a substantial proportion of patients in whom oral nabilone are safe and effective beyond placebo effects
Nabilone is currently used to treat conditions other that uremic pruritus including chronic nerve pain as well as nausea and vomiting due to chemotherapy It has never been studied in the setting of kidney disease
DISCO-POT is a blinded placebo-controlled crossover trial in which participants will be followed for 11 weeks including two 4 week treatment crossover periods with a 2 week washout period in between them and an end of study visit after 1 week off study drugs
Patients that are eligible will be randomly assigned to a crossover treatment sequence of two treatments
1 nabilone 05 mg orally at night for 1 week increased to nabilone 05mg orally twice a day for 3 weeks over-encapsulated
2 placebo 1 capsule orally at night for 1 week increased to placebo 2 capsules twice a day for 3 weeks over-encapsulated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None