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A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.


Phase 3
18 Years
75 Years
Not Enrolling
Both
Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

Thank you

Trial Information

A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.


Inclusion Criteria:



Subjects that have insufficiently treated, cancer-related chronic pain that requires
long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky
performance status above 50.

1. Subject informed consent given.

2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy
test and adequate contraception.

3. No significant skin lesions on relevant surfaces on the body or diffuse skin
diseases.

4. No impaired respiratory function nor neurological or psychiatric impairment.

5. No known abuse of drug, narcotic or alcohol.

6. Not pregnant or nursing.

7. Not hypersensitive/allergic to fentanyl or morphine.

8. No head injury, primary brain tumor, increased intracranial pressure or impaired
consciousness.

9. Not participating in other clinical trials.

Exclusion Criteria:

All exclusion criteria must be answered No for a patient to participate in the trial.

1. Does the patient have significant skin lesions on the upper arms/flat surface of the
upper torso or diffuse skin disease (psoriasis or eczema) that preclude application
of fentanyl patches?

2. Does the patient have a known abuse of drug, narcotic or alcohol?

3. Is the patient pregnant or nursing?

4. Has the patient neurological or mental impairment that may compromise data
collection?

5. Is the patient hypersensitive/allergic to fentanyl or morphine or any of the
ingredients in the trial medication?

6. Has the patient any major head injury, primary brain tumour, increased intracranial
pressure or impaired consciousness?

7. Does the patient participate in other clinical with other investigational drugs or
investigation al medical devices or has been participating in such a trial for the
past 30 days?

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary:

Principal Investigator

Nycomed Clinical Project Management

Investigator Role:

Study Chair

Investigator Affiliation:

Headquaters

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

FT-015-IN

NCT ID:

NCT00279344

Start Date:

September 2004

Completion Date:

August 2007

Related Keywords:

  • Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

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