A Phase 2 interventional study of Fentanyl citrate and Placebo in Breakthrough Pain, sponsored by UNICANCER. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by UNICANCER · Phase 2, Interventional, and Treatment
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:
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:
Secondary objectives (phase II and cohort):
Secondary objectives (phase II only):
Inclusion Criteria:
Patients:
Patients need to have at least one of the following interventions, lasting between 25 and 45 minutes during which they will be request to not move:
(*) A patient who has numerous radiotherapy sessions can only be included once; (**) with acquisition phase in a prostrate or decubitus dorsal position and strictly immobile in one of the cameras (PET or SPECT).
Inclusion criteria (cohort):
As for the inclusion criteria for the phase II study, with the following modifications:
and with at least 60 mg per day of oral morphine, or at least 30 mg/day of oral oxycodone, or at least 8 mg/day of oral hydromorphone, or at least 25 µg/h of transdermal fentanyl.
Or
Patients experience breakthrough pain (numerical pain scale 5), in a region corresponding to the localization of the metastatic lesions or the primary tumor, when they assume a prostrate/decubitus dorsal position,
Or
Patients who have breakthrough pain (numerical pain scale 5) in a region corresponding to the localization of the metastatic lesions or the primary tumor that prevents the completion of a diagnostic or therapeutic examination/intervention.
Exclusion Criteria:
Drug: Fentanyl citrate
Drug: Placebo
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
one intake of placebo (intranasal or buccal)
Successful diagnostic or therapeutic examination
A patient will be considered a success if the planned immobilization period is completed.
Time frame: 1 hours after randomization
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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