Breakthrough Pain Clinical Trial
Official title:
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.
Primary objective (phase II trial):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain
caused by positional requirements of a diagnostic or therapeutic intervention/examination in
cancer patients who do not meet the prescription criteria for fentanyl citrate's marketing
authorisation, as follows:
- Patients having received less than 60 mg of slow-release/extended-release morphine.
- Patients having received slow-release/extended-release morphine for less than 7 days.
- Patients who have not received any opioid treatment.
Primary objective (cohort):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain
caused by positional requirements of a diagnostic or therapeutic intervention/examination in
cancer patients when used within the marketing authorisation, as follows:
- Patients having at least 60 mg of slow-release/extended-release morphine.
- Patients having received slow-release/extended-release morphine for at least 7 days.
- Patients who have already received an opioid treatment (at least equivalent to 60 mg
/day of oral morphine) for chronic cancer-related pain for at least 7 days.
Secondary objectives (phase II and cohort):
- Evaluate the tolerance of the administration of fentanyl citrate when used to alleviate
breakthrough pain caused by positional requirements of a diagnostic or therapeutic
intervention/examination in cancer patients.
- Evaluate the efficacy of fentanyl citrate for reducing pain.
- Evaluate the efficacy of fentanyl citrate for reducing anxiety.
- Evaluate the percentage of relief and patients' satisfaction related to the
administration of fentanyl citrate.
Secondary objectives (phase II only):
• Describe the reasons why the diagnostic or therapeutic intervention/examination failed.
;
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