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PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy

NCT01980498 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-10-07

No results posted yet for this study

Summary

The primary objective of the present phase IIIb study is to assess the efficacy of FPNS compared with Physician Choice-Usual Care (PC-UC) in the reduction of swallowing predictable BTP in head and neck cancer patients undergoing radiotherapy with or without chemotherapy.

Conditions

  • Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain

Interventions

DRUG

Fentanyl pectin nasal spray (FPNS)

The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.

DRUG

Physician choice-Usual care (PC-UC)

The PC-UC will be started at a dose according to the physician choice. If this dose of PC-UC is effective on pain control, at the following meal the patient will take the same dose of PC-UC. If the dose of PC-UC results non effective on pain control, at the following meal the patient will take an increased dose of the same PC-UC drug or change the PC-UC drug, according to the physician choice.

Sponsors & Collaborators

  • Consorzio Mario Negri Sud

    collaborator OTHER

  • L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

    lead INDUSTRY

Principal Investigators

  • Lisa Licitra, MD · Fondazione IRCCS - Istituto Nazionale Tumori - Milano (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01980498 on ClinicalTrials.gov