| Source of record | UK Trials |
| ISRCTN | ISRCTN34797860 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | FEN-INT-15 |
| Public title | A Study to Compare the Safety and Efficacy of Durogesic with Sustained Release Morphine in Patients with Cancer Pain Transferring from Weak to Strong Opioids |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer pain |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged over 18 years old
2. Histologically, radiologically or haematologically confirmed malignancy, whose pain is judged by the investigator to be caused by the malignancy
3. Patients whose pain has reached a stage now requiring treatment with a strong opioid
4. Patients who have received a regular weak opioid, for at least 48 hours and at a dosage appropriate for their pain at that time
5. Not previously received regular treatment with a strong opioid for their cancer pain. This should have not exceeded more than three doses of a strong immediate release opioid in the last 7 days, and none in the last 24 h
6. No planned treatment within the next 24 h which may alter abruptly the degree or nature of pain experienced
7. No current or planned cytotoxic chemotherapy
8. No medical contraindications to protocol treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1997 |
| Anticipated end date | 31/12/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm A: Durogesic (transdermal fentanyl) commencing at 25 µg/h with rescue analgesia as needed.
2. Arm B: Sustained release morphine commencing at 30 mg twice daily with rescue analgesia as needed. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Janssen-Cilag Ltd (UK) |
| Sponsor name | Janssen-Cilag Ltd (UK) |
| Sponsor details | Saunderton
High Wycombe
United Kingdom
HP14 4HJ |
| Sponsor website | http://www.janssen-cilag.co.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN34797860 |
| Date last extracted from ISRCTN register | 17/04/2008 |
