Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-02-18 @ 10:40 AM
Study NCT ID:
NCT02050503
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059390', 'term': 'Breakthrough Pain'}, {'id': 'D052016', 'term': 'Mucositis'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-01-29', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'safety of intranasal transmucosal fentanyl', 'timeFrame': '7 days', 'description': '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)'}], 'primaryOutcomes': [{'measure': 'Pain Intensity Difference', 'timeFrame': '30 minutes after PecFent administration', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication', 'timeFrame': '12 episodes of breakthrough pain presenting within a maximum of 7 days.', 'description': 'The number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication.\n\nPatient rating of drug efficacy measured on a scale from 0 to 10 (0 = ineffective, 10 = totally effective).\n\nQuality 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.\n\nPatient rating of drug ease of use measured on a scale from 1 to 4 (1 = very complicated, 4 = very simple).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mucositis', 'Breakthrough pain', 'Head Nad neck cancer', 'Intranasal transmucosal fentanyl in pectin'], 'conditions': ['Breakthrough Pain', 'Mucositis', 'Radiotherapy', 'Chemotherapy', 'Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nStudy 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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults of either sex and over 18 and under 75 years of age, receiving continued treatment with long half-life or controlled release opioids, experiencing breakthrough pain secondary to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA 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\n\nExclusion Criteria:\n\n* Patients without controlled release opioid treatment.'}, 'identificationModule': {'nctId': 'NCT02050503', 'acronym': 'CP073', 'briefTitle': 'Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'Grupo de Investigación Clínica en Oncología Radioterapia'}, 'officialTitle': 'Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis', 'orgStudyIdInfo': {'id': 'CP073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'intranasal transmucosal fentanyl pectin', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28220', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Alejandro de la Torre. Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}], 'overallOfficials': [{'name': 'Alejandro De la Torre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GICOR & Hospital Puerta de Hierro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo de Investigación Clínica en Oncología Radioterapia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}