Contact information
Type
Scientific
Contact name
Prof Janet Hardy
ORCID ID
Contact details
c/o Palliative Care
Mater Adult Hospital
Raymond Terrace
South Brisbane
Qld 4101
Australia
+61 7 3163 8630
janet.hardy@mater.org.au
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0258107458
Study information
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
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/08/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Multicentre 85 patients.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
85
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2001
Recruitment end date
01/08/2003
Locations
Countries of recruitment
Australia, United Kingdom
Study 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
Hospital/treatment centre
Funder name
The Royal Marsden NHS Foundation Trust (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|