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

ISRCTN	ISRCTN34797860
DOI	https://doi.org/10.1186/ISRCTN34797860
Secondary identifying numbers	FEN-INT-15

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific 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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer pain
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	fentanyl, morphine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1997
Completion date	31/12/1999

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/1997
Date of final enrolment	31/12/1999

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Janssen-Cilag Ltd (UK)
Industry

Saunderton
High Wycombe
HP14 4HJ
United Kingdom

Website	http://www.janssen-cilag.co.uk
"ROR"	https://ror.org/03qwpn290

Industry

Janssen-Cilag Ltd (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/1997	26/03/2020	Yes	No

26/03/2020: Publication reference added.