Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy

NCT02426697 | Completed Phase 3

• 1 other identifier: CHB14.03
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bone Metastasis

Keywords

bone metastasis, radiotherapy, pain, prevention

Outcome Measures

Primary Outcomes (1)

• 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

  30 minutes

Secondary Outcomes (4)

• Patient global satisfaction

  one week

• Adverse event of Pecfent

  one week

• Rescue medication

  30 minutes

• Radiotherapy session duration

  one hour

Study Arms (2)

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)

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)

Drug: Placebo

Interventions

Placebo DRUG

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).

Also known as: Placebo in transmucosal use

Placebo

fentanyl transmucosal DRUG

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).

Also known as: Pecfent

Pecfent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Pain

Interventions

Fentanyl; Administration, Mucosal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sébastien Thureau, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: May 22, 2015
• Primary Completion: April 24, 2020
• Study Completion: April 30, 2020
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)