A randomised, placebo-controlled, double-blind trial of ondansetron in renal itch

ISRCTN	ISRCTN75728112
DOI	https://doi.org/10.1186/ISRCTN75728112
Secondary identifying numbers	RRCC144R MURPHY

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michelle Murphy
Scientific

Department of Dermatology
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Phone	+44 (0)1642 854721

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Patients will be randomised to receive either ondansetron 8 mg tbs or a lactulose placebo tbs for one week. Lactulose is the other constituent of ondansetron preparations. Neither the patient or investigating doctors will be aware of which treatment the patient has received. Following a one week wash-out period the patients will be switched to the other treatment according to the cross-over design. Patients will be followed up for one week following cessation of treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Renal itch
Intervention	1. Ondansetron 8 mg tbs 2. Lactulose placebo tbs for one week
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ondansetron, lactulose
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	06/01/2000
Completion date	11/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	25
Key inclusion criteria	Twenty-five patients will be recruited from the renal dialysis unit, only patients on haemodialysis will be included. Patients with a history of pruritus for more than eight weeks will be given a visual analogue scale to assess the severity of pruritus twice a day for one week. Those patients with a mean peak value greater than 5 out of 10 for the last five days of the week will be included.
Key exclusion criteria	Patients will be excluded if they have concomitant dermatological disease associated with pruritus as assessed by a dermatologist (MM) or another metabolic cause of itch.
Date of first enrolment	06/01/2000
Date of final enrolment	11/01/2000

Department of Dermatology

Sunderland
SR4 7TP
United Kingdom

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2003		Yes	No