Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis (CP073)
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|ClinicalTrials.gov Identifier: NCT02050503|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : March 17, 2015
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
|Condition or disease|
|Breakthrough Pain Mucositis Radiotherapy Chemotherapy Head and Neck Cancer|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
intranasal transmucosal fentanyl pectin
intranasal transmucosal fentanyl in pectin (100, 200, 400 or 800 microg) intranasal route titration phase 7 days treatment phase until completing treatment of 12 consecutive episodes of breakthrough pain
- 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
- number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication [ Time Frame: 12 episodes of breakthrough pain presenting within a maximum of 7 days. ]
The number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication.
Patient rating of drug efficacy measured on a scale from 0 to 10 (0 = ineffective, 10 = totally effective).
Quality of life assessed with the European Organization for Research and Treatment of Cancer quality of life questionnaire -INF025 in its validated Spanish version, administered on the screening visit and at the end of the study.
Patient rating of drug ease of use measured on a scale from 1 to 4 (1 = very complicated, 4 = very simple).
- safety of intranasal transmucosal fentanyl [ Time Frame: 7 days ]The appearance of adverse effects during the study Physical examination at each visit Vital signs: blood pressure, pulse Concomitant medication for breakthrough pain Reasons for patient study withdrawal (in the event of withdrawal)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050503
|Alejandro de la Torre. Hospital Puerta de Hierro|
|Majadahonda, Madrid, Spain, 28220|
|Principal Investigator:||Alejandro De la Torre, MD||GICOR & Hospital Puerta de Hierro|