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

Information source: Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer

Phase: N/A

Status: Completed

Sponsored by: Grupo de Investigación Clínica en Oncología Radioterapia

Official(s) and/or principal investigator(s):
Alejandro De la Torre, MD, Principal Investigator, Affiliation: GICOR & Hospital Puerta de Hierro

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Pain Intensity Difference

Secondary outcome: number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Alejandro de la Torre. Hospital Puerta de Hierro, Majadahonda, Madrid 28220, Spain
Additional Information

Starting date: December 2012
Last updated: March 16, 2015

Page last updated: August 23, 2015

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