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NCT06159686

The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus

Completed Phase 1, PHASE2 Last updated 27 March 2024
What this trial tests

Phase 1, PHASE2 trial testing Hemp in Uremic Pruritus in 60 participants. Completed in 8 December 2023.

Timeline
15 September 2023
Primary endpoint
8 December 2023
8 December 2023

Quick facts

Lead sponsorThammasat University Hospital
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date15 September 2023
Primary completion8 December 2023
Estimated completion8 December 2023
Sites1 location across Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Thammasat University Hospital

Who can join

18 and older, any sex, with Uremic Pruritus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms. This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cannabis-Containing Cream for CKD-Associated Pruritus: A Double-Blind, Placebo Controlled Trial.
    Anumas S, Kuropakornpong P, Chakkavittumrong P, Tasanarong A, et al · · 2024 · cited 4× · PMID 39328960 · DOI 10.1016/j.xkme.2024.100894

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Other recruiting trials for Uremic Pruritus

Currently open trials in the same condition.

Other Thammasat University Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06159686.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing