临床试验/NCT00924664

NCT00924664终止2 期

A RANDOMIZED, MULTICENTER, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC LOW BACK PAIN

Pfizer149 个研究点分布在 1 个国家目标入组 849 人开始时间: 2009年8月20日最近更新: 2021年4月21日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Pfizer
入组人数: 849
试验地点: 149
主要终点: Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8

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 purpose of this study is to investigate the safety and efficacy of tanezumab for chronic low back pain. Patients who were randomized and treated with study medication in a previous chronic low back pain "parent" study will be eligible to enroll in this safety extension study at the Preferred Rollover Time Point visit or at the Early Termination visit of the parent study upon discontinuation due to lack of efficacy.

详细描述

This study was terminated on 30 November 2010 following a US FDA clinical hold for tanezumab chronic low back pain clinical studies which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Written informed consent prior to completing any of the study procedures.
•Female patients must meet one of the following criteria:
•1) Female patients of non childbearing potential - Must be post menopausal, defined as women who are >=45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels), or women who are amenorrheic for at least 1 year AND have a serum Follicle Stimulating Hormone (FSH) level greater than 30 IU/L at Screening for the parent double blind CLBP study; or Must be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy.
•2.) Female patients of child bearing potential: must not be pregnant or lactating, and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method), and must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing
•Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
•Females of child bearing potential and males must be willing to use approved methods of contraception from commencement of screening procedures until 16 weeks after the last dose of IV study medication.
•Patient must be able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures
•Patient has been treated in a parent tanezumab double blind CLBP study
•Patient has completed the Preferred Rollover Time Point visit of the double blind CLBP parent study or has been withdrawn for lack of efficacy. At least eight weeks but no more than 12 weeks have elapsed since the last study medication infusion in the parent study. Patients are permitted to enter the extension study up to 12 weeks after their last dose of study medication in their parent study (or 4 weeks after the End of Treatment visit)

排除标准

•Failed screening in a parent tanezumab double blind CLBP study
•Withdrawn from a parent tanezumab double blind CLBP study for an adverse event
•Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to become pregnant during the course of clinical study
•Use of any investigational medication within 30 days prior to Baseline (3 months for any investigational biological other than tanezumab) or plans to receive an investigational medication other than the study medication during the course of this study
•Patients who exited the parent double blind CLBP study because of lack of compliance, protocol violation (including not meeting entrance criteria), no longer willing to participate (for reasons other than lack of efficacy), or were lost to follow up in the parent double blind study
•Patients who were randomized into the parent study in violation of inclusion or exclusion criteria but who were not withdrawn from the parent study;
•Any other condition, which in the opinion of the Investigator, would put the patient at increased safety risk or otherwise make the patient unsuitable for this study

研究组 & 干预措施

Tanezumab 20 mg

Experimental

干预措施: Tanezumab 20 mg (Biological)

Tanezumab 10 mg

Experimental

干预措施: Tanezumab 10 mg (Biological)

结局指标

主要结局

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8

时间窗: A4091012: Baseline, A4091039: Week 8

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Baseline up to 112 days after last dose of study treatment (up to 448 days)

AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state.

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4

时间窗: A4091012: Baseline, A4091039: Week 4

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24

时间窗: A4091012: Baseline, A4091039: Week 24

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48

时间窗: A4091012: Baseline, A4091039: Week 48

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4

时间窗: A4091012: Baseline, A4091039: Week 4

BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes).

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8

时间窗: A4091012: Baseline, A4091039: Week 8

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56

时间窗: A4091012: Baseline, A4091039: Week 56

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8

时间窗: A4091012: Baseline, A4091039: Week 8

BPI-sf: 11-item self-report questionnaire consists of 5 questions, assess severity and impact of pain on daily functions. Q1-Q4 measure impact of pain (worst, least, average, right now). Q5 (7 items) measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). 7 items in Q5 averaged to obtain function composite score, range: 0 to 10; higher score=greater impairment.

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 40

时间窗: A4091012: Baseline, A4091039: Week 40

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32

时间窗: A4091012: Baseline, A4091039: Week 32

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56

时间窗: A4091012: Baseline, A4091039: Week 56

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24

时间窗: A4091012: Baseline, A4091039: Week 24

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48

时间窗: A4091012: Baseline, A4091039: Week 48

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 24

时间窗: A4091012: Baseline, A4091039: Week 24

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16

时间窗: A4091012: Baseline, A4091039: Week 16

Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40

时间窗: A4091012: Baseline, A4091039: Week 40

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32

时间窗: A4091012: Baseline, A4091039: Week 32

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40

时间窗: A4091012: Baseline, A4091039: Week 40

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4

时间窗: A4091012: Baseline, A4091039: Week 4

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16

时间窗: A4091012: Baseline, A4091039: Week 16

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 32

时间窗: A4091012: Baseline, A4091039: Week 32

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 8

时间窗: A4091012: Baseline, A4091039: Week 8

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16

时间窗: A4091012: Baseline, A4091039: Week 16

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 16

时间窗: A4091012: Baseline, A4091039: Week 16

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 32

时间窗: A4091012: Baseline, A4091039: Week 32

Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range: 1-5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities).

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 48

时间窗: A4091012: Baseline, A4091039: Week 48

Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 56

时间窗: A4091012: Baseline, A4091039: Week 56

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 24

时间窗: A4091012: Baseline, A4091039: Week 24

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 56

时间窗: A4091012: Baseline, A4091039: Week 56

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 8

时间窗: A4091012: Baseline, A4091039: Week 8

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 56

时间窗: A4091012: Baseline, A4091039: Week 56

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4

时间窗: A4091012: Baseline, A4091039: Week 4

RMDQ: back-specific, participant administered questionnaire that assess how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible RMDQ score: 0 to 24, with higher scores indicated greater disability.

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 32

时间窗: A4091012: Baseline, A4091039: Week 32

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 40

时间窗: A4091012: Baseline, A4091039: Week 40

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 16

时间窗: A4091012: Baseline, A4091039: Week 16

Change From A4091012 (NCT00876187) Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 48

时间窗: A4091012: Baseline, A4091039: Week 48

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 24

时间窗: A4091012: Baseline, A4091039: Week 24

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 48

时间窗: A4091012: Baseline, A4091039: Week 48

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 4

时间窗: A4091012: Baseline, A4091039: Week 4

Change From A4091012 (NCT00876187) Baseline in Patient Global Assessment of Low Back Pain at Week 40

时间窗: A4091012: Baseline, A4091039: Week 40

次要结局

Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 56)
Plasma Concentration of Tanezumab(Baseline (Day 1), Week 8, 24, 40, 56, 64)
Total Nerve Growth Factor (NGF) Concentration(Baseline (Day 1), Week 8, 24, 40, 56, 64)

研究者

发起方

Pfizer

申办方类型

Industry

责任方

Sponsor

研究点 (149)

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