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 |
| Protocol serial number | N0258107458 |
| Sponsor | Department of Health (UK) |
| Funder | The Royal Marsden NHS Foundation Trust (UK) |
- 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
Scientific
c/o Palliative Care
Mater Adult Hospital
Raymond Terrace
South Brisbane
Qld 4101
Australia
| Phone | +61 7 3163 8630 |
|---|---|
| janet.hardy@mater.org.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine |
| Primary outcome measure(s) |
To provide an evidence base for overnight administration regimes for patients receiving normal release morphine for cancer pain. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- Australia
Study participating centre
Mater Adult Hospital
South Brisbane
Qld 4101
Australia
Qld 4101
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2018: No publications found, verifying study status with principal investigator
