A Study On The Efficacy Of Delta-9-Tetrahydrocannabinol (Dronabinol) In Renal Itch

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000817-37-GB

Enrollment

Registered

2005-05-27

Start date

2005-06-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch associated with chronic renal failure

Interventions

Trade Name: Marinol® Product Name: Dronabinol Pharmaceutical Form: Capsule* CAS Number: 1972-08-3 Other descriptive name: Delta-9-tetrah

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic renal failure treated with continuous ambulatory peritoneal dialysis (CAPD) with a history of pruritis for more than 8 weeks. Patients with haemoglobin level =11g/dl. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with concomitant dermatological disease or another metabolic cause of itch. Patients with history of poor concordance Patients who are pregnant, planning to conceive or refuse to take adequate precaution to avoid pregnancy History of psychotic illnesses, schizophrenia, and any other mental illnesses. Mild depression will not be exclude participation but severe depression requiring electroconvulsive therapy (ECT) or inpatient treatment will be excluded Patients who refuse to abstain from driving during the study Those with a history of allergy to delta-9-THC or its related compounds or constituents of dronabinol Patients with unstable cardiac diseases such as uncontrolled hypertension, acute coronary syndrome and uncontrolled arrythmia as delta-9-THC may cause hypo- or hypertension and tachycardia. However, patients with stable cardiac conditions will not be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: : To assess the efficacy of oral delta-9-tetrahydrocannabinol (delta-9-THC) in patients with itch associated with chronic renal failure;Secondary Objective: To establish the pharmacokinetics of delta-9-THC in patients with chronic renal failure.;Primary end point(s): To demonstrate whether delta-9-THC is effective in treatment of renal itch when compared with placebo using a two-grouped t-test (statistical significance level p=0.05)	—

Measure

Time frame

Main Objective: : To assess the efficacy of oral delta-9-tetrahydrocannabinol (delta-9-THC) in patients with itch associated with chronic renal failure;Secondary Objective: To establish the pharmacokinetics of delta-9-THC in patients with chronic renal failure.;Primary end point(s): To demonstrate whether delta-9-THC is effective in treatment of renal itch when compared with placebo using a two-grouped t-test (statistical significance level p=0.05)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026