Effectiveness & Tolerance of Fentanyl Citrate in Painful Pain Induced

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Breakthrough Pain

Clinical Trial Details

NCT number	NCT03809455
Study type	Interventional
Source	UNICANCER
Contact
Status	Withdrawn
Phase	Phase 2
Start date	February 1, 2020
Completion date	February 1, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients — FARADI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms