Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
25/05/2016
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 Anthony Maraveyas

ORCID ID

Contact details

Department of Oncology
The Princess Royal Hospital
Salthouse Road
Hull
HU8 9HE
United Kingdom
-
mdsam@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084096585

Study information

Scientific title

A randomised phase II trial of the antiemetic effects of Nozinan® compared to a standard dexamethasone containing protocol

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Dexamethasone, levomepromazine (Nozinan®), metoclopramide (Maxalon®)

Primary outcome measures

Reduction in emesis.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

196 Patients, 93 in each arm.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

186

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2000

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Oncology
Hull
HU8 9HE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Industry

Funder name

Link Pharmaceuticals (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes

25/05/2016: No publications found, verifying study status with principal investigator