A randomised, placebo-controlled, double-blind trial of ondansetron in renal itch
| ISRCTN | ISRCTN75728112 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75728112 |
| Protocol serial number | RRCC144R MURPHY |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michelle Murphy
Scientific
Scientific
Department of Dermatology
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
| Phone | +44 (0)1642 854721 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ondansetron, lactulose |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 11/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Dermatology
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2003 | Yes | No |
