NCT01146561终止2 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 2
- 试验地点
- 17
- 主要终点
- Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8
研究概览
简要总结
Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
详细描述
On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female
- •Written informed consent
- •Diagnosis of chronic pancreatitis based on imaging studies
- •Persistent abdominal pain due to chronic pancreatitis
- •Qualifying pain score during the pre-treatment period
- •Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control
排除标准
- •Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study
- •Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction
- •Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months
- •History of alcoholism (within 1 year of screening) or concurrent alcohol abuse
- •History of cancer in the past years
- •Significant cardiac disease within 6 months
- •History, diagnosis or signs and symptoms of significant neurologic disease
- •Disqualifying laboratory values including Hepatitis B or C, HIV and drug test
- •Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator
- •Known history of rheumatoid arthritis
- •Avascular necrosis of the bone
- •History of trauma to a major joint Evidence of osteoarthritis
结局指标
主要结局
Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8
时间窗: Baseline, Week 1 to 8
Daily average chronic pancreatitis pain is assessed with an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score(Week 8)
- Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score(Week 8)
- Serum Nerve Growth Factor (NGF) Levels(Baseline (pre-dose), Week 8, 16)
- Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16(Baseline, Week 4, 8, 12)
- Number of Participants With Injection Site Reaction(Day 1 up to Week 16)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Baseline up to Week 16)
- Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16(Baseline, Week 8, 16)
- Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period(Baseline, Week 1 to 8)
- Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis(Weeks 4, 8, 16)
- Neuropathy Impairment Score (NIS)(Baseline and Weeks 2, 4, 8, 16)
- Plasma Tanezumab Levels(Baseline (pre-dose), Week 2, 4, 8, 16)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 112 days after the dose of study medication (up to 113 days))
- Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and 16(Baseline, Week 8, 16)
- Number of Participants With Anti Drug Antibody(Baseline, Week 8, 16)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to Week 16)
研究者
研究点 (17)
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