Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michelle Murphy

ORCID ID

Contact details

Department of Dermatology
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)1642 854721

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12588385

Publication citations

  1. 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.

Additional files

Editorial Notes