Breakthrough PainPhase 2FARADINCT03809455
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
A Phase 2 study testing Fentanyl citrate in people with Breakthrough Pain, run by UNICANCER.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain
- What is being tested?
- Fentanyl citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Patients in follow up or being treated for cancer.
- Patients with cancer-related pain (area of pain located near primary tumor or metastatic lesions).
- Patients:
- not having received any opioid treatment (opioid naïve).
- or, treated for less than 7 days by a slow-releasing/extend-release opioid treatment; and/or by less than 60 mg per day of oral morphine, or less than 30 mg/day of oral oxycodone, or less than 8 mg/day of oral hydromorphone, or less than 25 µg/h of transdermal fentanyl.
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- 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:
- Radiotherapy session*, including tomography (patients hospitalized or treated as outpatients).
- Dosimetric scanner (hospitalized patients).
- Positron-emission tomography** (PET): PET-computed tomography [CT] scan and single photon emission computed tomography [SPECT]-CT scan (hospitalized patients).
- Public health insurance coverage.
- () 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).
- As for the inclusion criteria for the phase II study, with the following modifications:
- 4. Patients treated with a slow-releasing/extended-release opioid for:
- more than 7 days.
- 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.
- 5. Patients who believes that they are cannot assume a prostrate or decubitus dorsal position for a diagnostic or therapeutic examination/intervention due to the pain they will experienced in this position,
- 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.
- 6. Public health insurance coverage.
Who cannot join
- Patients with contraindication for the administration of fentanyl citrate: severe respiratory depression or a severe obstructive pulmonary disease.
- Patients who have already participated in this study.
- Patients with a history of alcoholism or substance/drug dependence.
- Patients with an intravenous or subcutaneous opioid patient-controlled analgesic (PCA) pump.
- Patients unable to communicate or understand instructions in French.
- Patients deprived of their liberty or under protective custody or guardianship, or unable to provide their consent for study participation.
- Patients who are pregnant or breast-feeding.
About this study
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.
Read the detailed 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.
- Conditions
- Breakthrough Pain
- Being tested
- Fentanyl citrate, Placebo
- Keywords
- Breakthrough Pain
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl citrateDrug
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
PlaceboDrug
one intake of placebo (intranasal or buccal)
| Study group | Role | What they receive |
|---|---|---|
| FAR Arm | Experimental | Not described Receives: Drug: Fentanyl citrate |
| Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful diagnostic or therapeutic examination
A patient will be considered a success if the planned immobilization period is completed.
Measured: 1 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Why it stopped: Study was cancelled by Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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) Stratified by: * Centre * Type of examination: diagnostic (PET-CT scan or SPECT-CT scan) versus therapeutic (radiotherapy, tomotherapy, or dosimetric scanner)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809455
- Sponsor's protocol ID
- UC-0106/1607 SdS 02 FARADI
- Acronym
- FARADI
- Status last verified
- Apr 2020
- First submitted
- 11 Oct 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
- ClinicalTrials.gov ID
- NCT03809455
- Acronym / sponsor ID
- FARADI / UC-0106/1607 SdS 02 FARADI
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled by Sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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) Stratified by: * Centre * Type of examination: diagnostic (PET-CT scan or SPECT-CT scan) versus therapeutic (radiotherapy, tomotherapy, or dosimetric scanner)
| Arm | Type | Receives |
|---|---|---|
| FAR Arm | Experimental | Drug: Fentanyl citrate |
| Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥18 years.
- Patients in follow up or being treated for cancer.
- Patients with cancer-related pain (area of pain located near primary tumor or metastatic lesions).
- 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:
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl citrateFentanyl 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 | Drug | FAR Arm |
| Placeboone intake of placebo (intranasal or buccal) | Drug | Placebo Arm |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fentanyl citrate in people with Breakthrough Pain, run by UNICANCER.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful diagnostic or therapeutic examination (time frame: 1 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.