Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients (FARADI)
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|ClinicalTrials.gov Identifier: NCT03809455|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breakthrough Pain||Drug: Fentanyl citrate Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
The study will randomise patients (2:1; FAR Arm: Placebo Arm)
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2023|
|Experimental: FAR Arm||
Drug: Fentanyl citrate
Fentanyl citrate arm (FAR Arm): one intake of fentanyl citrate 100 µg (intranasal or buccal).
Placebo Arm: one intake of placebo (intranasal or buccal) The administration route will be left to the discretion of the investigator taking into account the patient's profile (capable of maintaining the sublingual tablet without swallowing, absence of nasal discharge…), and/or the patient's choice.
Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg Fentanyl citrate Abstral® Sublingual tablet Buccal 100 µg For the cohort the choice of treatment by FAR is at the centres discretion, according to standard of practice.
Treatment duration: 1 day
|Placebo Comparator: Placebo Arm||
one intake of placebo (intranasal or buccal)
- Successful diagnostic or therapeutic examination [ Time Frame: 1 hours after randomization ]A patient will be considered a success if the planned immobilization period is completed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809455
|Contact: Laurent LABREZE, MD, PHD||(0) 5 56 33 32 64 ext +firstname.lastname@example.org|
|Contact: Valérie PLENCE||(0)184.108.40.206.07 ext + email@example.com|