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Clinical Trials/NCT02050503
NCT02050503CompletedNot Applicable

Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis

Grupo de Investigación Clínica en Oncología Radioterapia1 site in 1 country33 target enrollmentStarted: December 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
33
Locations
1
Primary Endpoint
Pain Intensity Difference

Study Overview

Brief Summary

An open-label, non-randomized study to assess the titration, safety and efficacy of intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid therapy for chronic pain.

Study objectives include assessment of breakthrough pain episodes related with food intake in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck tumors

Detailed Description

An open, non-randomized study design was used to assess the titration, safety and efficacy of intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in patients with confirmed tolerance of opioid therapy for chronic pain secondary to radiation-induced mucositis. The study plans to include 30 evaluable patients from multiple centers throughout the country. The trial comprises a screening period, an open titration period, and an open-label treatment period in which at least 12 breakthrough pain episodes are to be treated.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A histologically confirmed diagnosis of head and neck carcinoma Treatment in the form of radiotherapy or radio-chemotherapy Breakthrough pain related to swallowing (one to four daily episodes) Treatment with controlled release opioids at the time of inclusion: at least 60 mg of morphine sulfate daily, at least 25 microg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily

Exclusion Criteria

  • Patients without controlled release opioid treatment.

Outcomes

Primary Outcomes

Pain Intensity Difference

Time Frame: 30 minutes after PecFent administration

Pain Intensity difference: Pain Intensity will be measured 30 min after starting food intake during the screening phase and 30 min after intranasal transmucosal fentanyl in pectin administration/food intake during the treatment phase

Secondary Outcomes

  • number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication(12 episodes of breakthrough pain presenting within a maximum of 7 days.)

Investigators

Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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