Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
04/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Janet Hardy

ORCID ID

Contact details

c/o Palliative Care
Mater Adult Hospital
Raymond Terrace
South Brisbane
Qld 4101
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0258107515

Study information

Scientific title

A randomised study to compare the effectiveness of hyoscine hydrobromide (Hyoscine) and glycopyrronium (Robinul) in the management of noisy breathing/retained secretions in cancer patients

Acronym

Study hypothesis

1. To compare the effectiveness of both hyoscine hydrobromide and glycopyrronium at relieving retained secretions at the time of death.
2. To test feasibility of the advanced 'consent process'.

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

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Noisy breathing, retained secretions

Intervention

Randomised test intervention versus standardised intervention, non-blinded (Phase 3).

Intervention type

Drug

Phase

Phase III

Drug names

Hyoscine hydrobromide, glycopyrronium

Primary outcome measures

1. Provide an evidence base for common practice
2. Provide a means of obtaining consent for research in dying patients

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/02/2002

Overall trial end date

28/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Total number of Royal Marsden Hospital patients 205

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

205

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

28/02/2002

Recruitment end date

28/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mater Adult Hospital
South Brisbane
Qld 4101
Australia

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

Charity

Funder name

The Royal Marsden NHS Foundation Trust (UK) Charitable Funds

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

07/12/2015: no publications found on PubMed. 04/01/2016: this study was abandoned in 2003.