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
Completed
Recruitment status
No longer recruiting

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

Additional identifiers

EudraCT 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Applicable

Drug names

Morphine

Primary outcome measures

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 trial start date

01/09/2001

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Multicentre 85 patients.

Participant type

Patient

Age group

Not Specified

Gender

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

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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes