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临床试验/NCT00985621
NCT00985621终止3 期

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Pfizer103 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2009年10月30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
3 期
状态
终止
发起方
Pfizer
入组人数
614
试验地点
103
主要终点
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
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 the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

详细描述

This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

排除标准

  • •pregnancy or intent to become pregnant
  • •BMI greater than 39
  • •other severe pain, significant cardiac, neurological or psychiatric disease

研究组 & 干预措施

1

Experimental

干预措施: tanezumab 10 mg (Biological)

2

Experimental

干预措施: tanezumab 5 mg (Biological)

3

Active Comparator

干预措施: oxycodone (Drug)

4

Placebo Comparator

干预措施: placebo (Other)

结局指标

主要结局

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population

时间窗: Baseline, Week 8

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population

时间窗: Baseline, Week 8

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain.

次要结局

  • Total Nerve Growth Factor (NGF) Serum Concentration(Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 12, and 16)
  • Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity(Baseline up to 112 days after last intravenous dose)
  • Tanezumab Plasma Concentration(Predose, 1 hour post-dose on Day 1, Week 8; Week 18)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Week 2, 4, 8, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With Rescue Medication (RM) Usage(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population(Week 8)
  • Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population(Week 8)
  • Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population(Weeks 2, 4, 8, 12, and 16)
  • Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population(Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population(Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16)
  • Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population(Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population(Baseline, Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population(Baseline, Week 12)
  • Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population(Baseline, Week 12)
  • Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population(Baseline, Week 12)
  • Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population(Baseline, Week 12)
  • Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population(Baseline, Week 12)
  • Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population(Baseline, Week 12)
  • Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population(Baseline, Week 12)
  • Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population(Baseline, Week 12)
  • Number of Participants Who Discontinued From Study Due to Lack of Efficacy(Baseline up to Week 24)
  • Time to Discontinuation From Study Due to Lack of Efficacy(Baseline up to Week 24)
  • Number of Days With Rescue Medication (RM) Usage(Weeks 2, 4, 8, 12, and 16)
  • Amount of Rescue Medication Used(Weeks 2, 4, 8, 12, and 16)
  • Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18(Baseline, Weeks 2, 4, 8, 12, 16, and 18)
  • Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)(Baseline, Week 8 and 18)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 112 days after last intravenous dose)
  • Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity(Baseline up to 112 days after last intravenous dose)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (103)

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