Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RRCC144R MURPHY
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Renal itch
Intervention
1. Ondansetron 8 mg tbs
2. Lactulose placebo tbs for one week
Intervention type
Drug
Phase
Not Specified
Drug names
Ondansetron, lactulose
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
06/01/2000
Overall trial end date
11/01/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
25
Participant 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.
Recruitment start date
06/01/2000
Recruitment end date
11/01/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12588385
Publication citations
-
Results
Murphy M, Reaich D, Pai P, Finn P, Carmichael AJ, A randomized, placebo-controlled, double-blind trial of ondansetron in renal itch., Br. J. Dermatol., 2003, 148, 2, 314-317.