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
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