Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FEN-INT-15
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Condition
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
Phase
Not Specified
Drug names
fentanyl, morphine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
31/12/1999
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/1997
Recruitment end date
31/12/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Janssen-Cilag Ltd (UK)
Sponsor details
Saunderton
High Wycombe
HP14 4HJ
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Janssen-Cilag Ltd (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
Basic results (scientific)
Publication list