CompletedNot Applicable

Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis

Spain33 participantsStarted 2012-12

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pain Intensity Difference

Timeframe: 30 minutes after PecFent administration

Trial details

NCT IDNCT02050503

SponsorGrupo de Investigación Clínica en Oncología Radioterapia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Breakthrough Pain trials