NCT00387010终止3 期
A 4-week Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain
Cephalon32 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 218
- 试验地点
- 32
- 主要终点
- Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
研究概览
简要总结
The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is willing to provide written informed consent to participate in this study.
- •The patient is 18 through 80 years of age.
- •Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and injected contraceptives must be used in conjunction with the barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study.
- •The patient has chronic pain of at least 3 months duration associated with any of the following conditions: cancer, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (patient has met diagnostic criteria), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with and written approval from the Cephalon medical expert.
- •The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-clock (ATC) therapy for at least 7 days prior to enrollment in the study.
- •The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for the chronic pain.
- •The patient experiences, on average, 1 to 4 BTP episodes per day while taking around-the-clock (ATC) opioid therapy, and on average, the duration of each breakthrough pain (BTP) episode is less than 3 hours.
- •The patient currently uses opioid therapy for alleviation of BTP episodes occurring at the location of the chronic pain, and achieves at least partial relief.
- •The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits and a follow-up evaluation as specified in this protocol.
排除标准
- •The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
- •The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
- •The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
- •The patient has cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of treatment with potent synthetic opioids.
- •The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
- •The patient's primary painful condition is headache, including migraine.
- •The patient is expected to have surgery during the study, and it is anticipated that the surgery will alleviate the patient's pain.
- •The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
- •The patient is pregnant or lactating.
- •The patient has participated in a previous study with fentanyl buccal tablets.
- •The patient has participated in a study involving an investigational drug in the previous 30 days.
- •The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
- •The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that, in the opinion of the investigator, would compromise the patient's safety or compliance with the study protocol, or compromise collected data.
- •The patient is involved in active litigation in regard to chronic pain currently being treated.
- •The patient has a positive urine drug screen (UDS) for an illicit substance or a medication not legitimately prescribed to the patient.
研究组 & 干预措施
fentanyl buccal tablets
Experimental
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
干预措施: Fentanyl Buccal Tablets (Drug)
结局指标
主要结局
Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
时间窗: Day 0 (baseline), approximately week 5
The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.
次要结局
- Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5(Day 0 (baseline), approximately week 5)
- Change From Baseline in the Beck Depression Inventory at Approximately Week 5(Day 0 (baseline), approximately week 5)
- Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5(Day 0 (baseline), approximately week 5)
- Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Go to Work at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Perform at Work at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Walk at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Exercise at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Participate in Social Events at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Have Sex at Approximately Week 5(approximately week 5)
- Patient Assessment of Ability to Enjoy Life at Approximately Week 5(approximately week 5)
- Clinical Assessment of Patient Function - General Activities - at Approximately Week 5(approximately week 5)
- Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5(approximately week 5)
- Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5(approximately week 5)
- Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5(approximately week 5)
- Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5(approximately week 5)
- Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)(up to 10 days)
研究者
研究点 (32)
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