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
| ISRCTN | ISRCTN87058979 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87058979 |
| Secondary identifying numbers | N0258107515 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 04/01/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
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
Prof Janet Hardy
Scientific
Scientific
c/o Palliative Care
Mater Adult Hospital
Raymond Terrace
South Brisbane
Qld 4101
Australia
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Noisy breathing, retained secretions |
| Intervention | Randomised test intervention versus standardised intervention, non-blinded (Phase 3). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Hyoscine hydrobromide, glycopyrronium |
| Primary outcome measure | 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 study start date | 28/02/2002 |
| Completion date | 28/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 205 |
| Key inclusion criteria | Total number of Royal Marsden Hospital patients 205 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 28/02/2002 |
| Date of final enrolment | 28/02/2005 |
Locations
Countries of recruitment
- Australia
- United Kingdom
Study participating centre
Mater Adult Hospital
South Brisbane
Qld 4101
Australia
Qld 4101
Australia
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Charity
The Royal Marsden NHS Foundation Trust (UK) Charitable Funds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/12/2015: no publications found on PubMed.
04/01/2016: this study was abandoned in 2003.
