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临床试验/NCT00584870
NCT00584870已完成2 期

PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN

Pfizer36 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2007年7月5日最近更新:
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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
220
试验地点
36
主要终点
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male or female of any race, >18 years of age and have BMI ≤39 kg/m2
  • •Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (>4 days per week for the past month)
  • •Primary location of low back pain is between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
  • •Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4

排除标准

  • •Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
  • •History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
  • •Osteoporotic compression fracture within the last 6 months
  • •Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
  • •Patients receiving acetaminophen only to manage their chronic low back pain
  • •Any uncontrolled or untreated chronic disease

研究组 & 干预措施

Naproxen

Active Comparator

干预措施: Naproxen (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

RN624

Experimental

干预措施: PF-04383119 (RN624) (Drug)

结局指标

主要结局

Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6

时间窗: Baseline, Week 6

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

次要结局

  • Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12(Baseline, Week 1, 2, 4, 8, 12)
  • Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12(Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12)
  • Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12(Baseline, Week 1, 2, 4, 6, 8, 12)
  • Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less(Week 1, 2, 4, 6, 8, 12)
  • Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6(Week 6)
  • Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score(Week 12)
  • Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score(Weeks 1, 2, 4, 6, 8, 12)
  • Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score(Randomization to Last Study Visit (up to 16 weeks))
  • Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score(Week 1 up to Week 12)
  • Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12(Baseline, Week 1, 2, 4, 6, 8, 12)
  • Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12(Baseline, Week 1, 2, 4, 6, 8, 12)
  • Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12(Week 1, 2, 4, 6, 8, 12)
  • Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication(Week 1, 2, 4, 6, 8, 12)
  • Number of Participants Who Discontinued the Study Due to Lack of Efficacy(Baseline up to Week 12)
  • Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 12)
  • Number of Participants With Chronic Low Back Pain (CLBP) Response(Weeks 1, 2, 4, 6, 8, 12)
  • Number of Participants Who Used Rescue Medications(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
  • Duration of Rescue Medication Use(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
  • Amount of Rescue Medication Taken(Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (36)

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