Condition category
Signs and Symptoms
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
05/11/2012
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

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

http://www.janssen-cilag.co.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes