A randomised phase II trial of the antiemetic effects of Nozinan® compared to a standard dexamethasone containing protocol
| ISRCTN | ISRCTN96357650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96357650 |
| Protocol serial number | N0084096585 |
| Sponsor | Department of Health (UK) |
| Funders | Link Pharmaceuticals (UK), NHS R&D Support Funding (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 25/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anthony Maraveyas
Scientific
Scientific
Department of Oncology
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
| mdsam@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised phase II trial of the antiemetic effects of Nozinan® compared to a standard dexamethasone containing protocol |
| Study objectives | How does the antiemetic effects of dexamethasone and levomepromazine (Nozinan®) compare in the treatment of delayed emesis in patients receiving a cisplatin-based chemotherapy regimen (ECF)? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Vomiting, delayed chemotherapy-induced emesis (DCIE) |
| Intervention | Randomised controlled trial comparing (a) study treatment (ie Nozinan®) and (b) standard treatment (ie dexamethasone and Maxolon®). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone, levomepromazine (Nozinan®), metoclopramide (Maxalon®) |
| Primary outcome measure(s) |
Reduction in emesis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 186 |
| Key inclusion criteria | 196 Patients, 93 in each arm. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Oncology
Hull
HU8 9HE
United Kingdom
HU8 9HE
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 |
Editorial Notes
25/05/2016: No publications found, verifying study status with principal investigator
