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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426697
Recruitment Status : Unknown
Verified July 2018 by Centre Henri Becquerel.
Recruitment status was:  Recruiting
First Posted : April 27, 2015
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Tracking Information
First Submitted Date  ICMJE April 22, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date July 23, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • Patient global satisfaction [ Time Frame: one week ]
    - 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
  • Adverse event of Pecfent [ Time Frame: one week ]
    Percentage of patient with side effects due to Pecfent
  • Rescue medication [ Time Frame: 30 minutes ]
    Percentage of patients needing rescue medication during radiotherapy session
  • Radiotherapy session duration [ Time Frame: one hour ]
    Duration of the session between the patient is discharged from the cabin until his return in the cabin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
Official Title  ICMJE Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bone Metastasis
Intervention  ICMJE
  • Drug: fentanyl transmucosal
    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).
    Other Name: Pecfent
  • Drug: Placebo
    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).
    Other Name: Placebo in transmucosal use
Study Arms  ICMJE
  • Experimental: Pecfent
    Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment)
    Intervention: Drug: fentanyl transmucosal
  • Placebo Comparator: Placebo
    Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 22, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426697
Other Study ID Numbers  ICMJE CHB14.03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Henri Becquerel
Study Sponsor  ICMJE Centre Henri Becquerel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sébastien Thureau, MD Centre Henri Becquerel
PRS Account Centre Henri Becquerel
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP