NCT00568321已完成2 期
A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH POST-HERPETIC NEURALGIA
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 99
- 试验地点
- 31
- 主要终点
- Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
研究概览
简要总结
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race, at least 18 years of age.
- •Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
- •Has a pain score at screening that qualifies.
- •Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
- •Body Mass Index less than or equal to 39 kg/m
- •If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
- •Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
- •Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Patients must consent in writing to participate in the study.
排除标准
- •Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
- •Disqualifying scores on questionnaires.
- •Other moderate to severe pain from other conditions.
- •History of allergic or anaphylactic reaction to antibodies.
- •Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
- •Unable to use acetaminophen.
- •Disqualify laboratory values, Hepatitis B or C or HIV.
- •Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
- •Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
- •Cancer other than basal cell or squamous cell carcinoma.
- •Fails a urine test for illegal drugs including prescription drugs without a prescription.
- •Plans for surgery during the study.
- •History of alcoholism or drug abuse in the past two years.
- •Surgery for post-herpetic neuralgia.
- •Any condition that the investigator feels would put the safety of the patient at risk.
研究组 & 干预措施
1
Experimental
干预措施: RN624 (Drug)
2
Active Comparator
干预措施: RN624 (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
时间窗: Baseline, Week 6
Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.
次要结局
- Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16(Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16)
- Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16(Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16)
- Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16(Baseline, Week 1, 2, 4, 8, 12, 16)
- Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16(Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6(Baseline, Week 6)
- Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6(Baseline, Week 6)
- Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score(Baseline up to Week 16)
- Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants(Baseline to Week 16)
- Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16(Baseline, Week 1, 2, 4, 6, 8, 12 and 16)
- Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16(Baseline, Week 1, 2, 4, 6, 8 ,12, 16)
- Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication(Week 1, 2, 4, 6, 8, 12, 16)
- Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16(Baseline, Week 1, 2, 4, 6, 8, 12, 16)
- Number of Participants Who Discontinued the Study Due to Lack of Efficacy(Baseline up to Week 16)
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 16)
- Number of Participants Who Used Rescue Medications(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- Duration of Rescue Medication Use(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- Amount of Rescue Medication Taken(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 112 days after the last dose of study drug (up to Week 16))
- Number of Participants With Abnormal Physical Examinations Findings at Screening(Screening visit (1 day prior to Day 1 baseline visit))
- Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16(Baseline, Week 16)
- Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16(Baseline, Week 16)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16(Baseline, Week 16)
- Number of Participants With Laboratory Abnormalities(Baseline up to Week 16)
- Number of Participants With Electrocardiogram (ECG) Abnormalities(Baseline up to Week 16)
- Number of Participants With Positive Anti-Drug Antibody (ADA) Response(Baseline up to Week 16)
- Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study(Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16))
- Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab(Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1)
研究者
研究点 (31)
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