A prospective study to compare the effectiveness of giving normal release morphine sulphate overnight on a regular 4 hourly basis or on an 'as required basis' in patients with cancer

ISRCTN	ISRCTN90932532
DOI	https://doi.org/10.1186/ISRCTN90932532
Secondary identifying numbers	N0258107458

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 14/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
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

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

Phone	+61 7 3163 8630
Email	janet.hardy@mater.org.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A prospective study to compare the effectiveness of giving normal release morphine sulphate overnight on a regular 4 hourly basis or on an 'as required basis' in patients with cancer
Study objectives	To explore the best way of administering normal release morphine overnight. To determine the difference in pain control, sleep disturbance, and patient preference between the two groups.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Pain management
Intervention	Randomised test intervention versus standardised intervention, non-blinded (Phase 3). Group A: On days 1 and 2, patients will be given 4 hourly morphine during the day and at 23.00 h, 03.00 h and 07.00 h at night. On days 3 and 4, patients will be given 4 hourly morphine during the day and a single dose of morphine at 23.00 h and a single 4 hourly dose at 07.00 h (ie omitting the 03.00 h dose) Group B: On days 1 and 2, patients will be given 4 hourly morphine during the day and a single dose of morphine at 23.00 h and a single 4 hourly dose at 07.00 h (ie omitting the 03.00 h dose). On days 3 and 4, patients will be given 4 hourly morphine during the day and at 23.00 h, 03,00 h and 07.00 h at night. In both Groups: all patients have the option of requesting a breakthrough dose of morphine at any time, equivalent to a single 4 hourly dose.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Morphine
Primary outcome measure	To provide an evidence base for overnight administration regimes for patients receiving normal release morphine for cancer pain.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2001
Completion date	01/08/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	85
Key inclusion criteria	Multicentre 85 patients.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2001
Date of final enrolment	01/08/2003

Locations

Countries of recruitment

Australia
United Kingdom

Study participating centre

Mater Adult Hospital

South Brisbane
Qld 4101
Australia

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Royal Marsden NHS Foundation Trust (UK)

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

14/02/2018: No publications found, verifying study status with principal investigator