Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis (CP073)
Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
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
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Madrid
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Majadahonda, Madrid, 스페인, 28220
- Alejandro de la Torre. Hospital Puerta de Hierro
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Intensity Difference
기간: 30 minutes after PecFent administration
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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
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30 minutes after PecFent administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
기간: 12 episodes of breakthrough pain presenting within a maximum of 7 days.
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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). |
12 episodes of breakthrough pain presenting within a maximum of 7 days.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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safety of intranasal transmucosal fentanyl
기간: 7 days
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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)
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7 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alejandro De la Torre, MD, GICOR & Hospital Puerta de Hierro
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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