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 |
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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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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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 |
Eligibility
Participant type(s) | Patient |
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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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Janssen-Cilag Ltd (UK)
Industry
Industry
Saunderton
High Wycombe
HP14 4HJ
United Kingdom
Website | http://www.janssen-cilag.co.uk |
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https://ror.org/03qwpn290 |
Funders
Funder type
Industry
Janssen-Cilag Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
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.