Bone MetastasisPhase 3PARABONENCT02426697
Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
A Phase 3 study testing fentanyl transmucosal in people with Bone Metastasis, run by Centre Henri Becquerel at 1 site in France.
Trial summary
The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis
- What is being tested?
- fentanyl transmucosal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2015to 30 Apr 2020
- Phase
- Phase 3
- 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
- Male or female
- More than 18 years old
- Proven histological cancer with bone metastasis
- SignedInform consent form
- Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session
Who cannot join
- VAS>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session
- Any SAO treatment on going
- Pregnant or lactating woman
- Hypersensitivity or safety issues to any opioïd treatment
- Poor nasal mucosa (defined on clinical doctor assessment)
- Severe obstructive lung conditions or respiratory depression
Show all 13Show fewer
- Renal insufficiency with creatinine clearance inferior to 45 ml/min
- Hepatic insufficiency
- Patient misunderstanding of the content and objective of the trial
- Patient under supervision or guardianship
- SAO intake 4 hours before the radiotherapy session
- Patient participating to any other pain management trial
- Morphine pump usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations
Read the detailed description
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). Patients with a VAS≤ 3 will be excluded.
PecFent and Placebo will be delivered by Archimedes Pharma When starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (Pecfent® ) 100µg in naive patients or 1 dose of Pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient VAS collected before and at the end of the radiotherapy session. Finally patient \& radiotherapists global satisfaction will be collected An assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a Patient global satisfaction
Study follow up:
Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
- Conditions
- Bone Metastasis
- Being tested
- fentanyl transmucosal, Placebo
- Keywords
- bone metastasis, radiotherapy, pain, prevention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl transmucosalDrug
Also called Pecfent
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).
PlaceboDrug
Also called Placebo in transmucosal use
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).
| Study group | Role | What they receive |
|---|---|---|
| Pecfent | Experimental | Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment) Receives: Drug: fentanyl transmucosal |
| Placebo | Placebo comparator | Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug efficacy
Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session
Measured: 30 minutes
Secondary outcomes (4)
Patient global satisfaction
- Patient Global Satisfaction Score [0 (not satisfied) to 5 (very satisfied) one week after the radiotherapy session. Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
Measured: one week
Adverse event of Pecfent
Percentage of patient with side effects due to Pecfent
Measured: one week
Rescue medication
Percentage of patients needing rescue medication during radiotherapy session
Measured: 30 minutes
Radiotherapy session duration
Duration of the session between the patient is discharged from the cabin until his return in the cabin
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start22 May 2015
- Primary completion24 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Thureau, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426697
- Sponsor's protocol ID
- CHB14.03
- Acronym
- PARABONE
- Status last verified
- Dec 2025
- First submitted
- 22 Apr 2015
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
- ClinicalTrials.gov ID
- NCT02426697
- Acronym / sponsor ID
- PARABONE / CHB14.03
- Conditions
- Bone Metastasis
- Keywords
- bone metastasis, radiotherapy, pain, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 22 May 2015 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 27 Apr 2015 (estimated)
- 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.
The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations
Detailed description
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). Patients with a VAS≤ 3 will be excluded.
PecFent and Placebo will be delivered by Archimedes Pharma When starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (Pecfent® ) 100µg in naive patients or 1 dose of Pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient VAS collected before and at the end of the radiotherapy session. Finally patient \& radiotherapists global satisfaction will be collected An assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a Patient global satisfaction
Study follow up:
Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pecfent | Experimental | Drug: fentanyl transmucosalPatients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment) |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- More than 18 years old
- Proven histological cancer with bone metastasis
- SignedInform consent form
- Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session
Key exclusion criteria (13 listed)
- VAS>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session
- Any SAO treatment on going
- Pregnant or lactating woman
- Hypersensitivity or safety issues to any opioïd treatment
- Poor nasal mucosa (defined on clinical doctor assessment)
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 transmucosalAlso: PecfentParticipation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session). | Drug | Pecfent |
| PlaceboAlso: Placebo in transmucosal useParticipation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session). | Drug | Placebo |
Primary outcome
Drug efficacy
Time frame: 30 minutes
Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session
4 secondary outcomes
Patient global satisfaction
Time frame: one week
Adverse event of Pecfent
Time frame: one week
Rescue medication
Time frame: 30 minutes
Radiotherapy session duration
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
Sébastien Thureau, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fentanyl transmucosal in people with Bone Metastasis, run by Centre Henri Becquerel at 1 site in France.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Drug efficacy (time frame: 30 minutes). 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 2 Jan 2026.