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
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
26/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleA 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer pain
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)fentanyl, morphine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1997
Completion date31/12/1999

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/1997
Date of final enrolment31/12/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Janssen-Cilag Ltd (UK)
Industry

Saunderton
High Wycombe
HP14 4HJ
United Kingdom

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

Funders

Funder type

Industry

Janssen-Cilag Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

26/03/2020: Publication reference added.