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A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS (ALBATROSS)

2013年1月16日 更新者：Menarini Group

Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

研究概览

地位

完全的

条件

干预/治疗

详细说明

MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

研究类型

介入性

注册 (实际的)

423

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Bad Doberan、德国、18209
        • Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan
      • Berlin、德国、10117
        • Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte
      • Berlin、德国、12247
        • Orthopädische Praxis Dr. Wagenitz
      • Bochum、德国、44787
        • ClinPharm International, Prüfzentrum Bochum
      • Dresden、德国、01067
        • ClinPharm International, Prüfzentrum Dresden
      • Erlangen、德国、91054
        • Medizinische Klinik 3, Universität Erlangen-Nürnberg
      • Frankfurt、德国、60596
        • ClinPharm Prüfzentrum Frankfurt / aM
      • Görlitz、德国、02826
        • ClinPharm Prüfzentrum Görlitz
      • Hamburg、德国、22143
        • Clinical Research Hamburg
      • Hamburg、德国、22767
        • Orthopädie Zentrum Altona
      • Leipzig、德国、04103
        • ClinPharm International, Prüfzentrum Leipzig
      • Magdeburg、德国、39104
        • ClinPharm Prüfzentrum Magdeburg
  • 意大利
      • Bologna、意大利、40138
        • Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli
      • Firenze、意大利、50139
        • Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi
      • Pisa、意大利、56126
        • Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa
      • Siena、意大利、53100
        • Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena
  • 法国
      • Orléans、法国、45000
        • Centre Hospitalier Régional - Hôpital Porte Madeleine
      • Paris、法国、75181
        • Hôtel Dieu - GHU Ouest
      • Toulouse、法国、31300
        • Department of Rheumatology, Purpan University Hospital
  • 西班牙
      • Bilbao、西班牙、48013
        • Servicio de Reumatologia, Hospital de Basurto
      • Madrid、西班牙、28046
        • Servicio de Reumatologia, Hospital Universitario La Paz
      • Sabadell、西班牙、08208
        • Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell
      • Sevilla、西班牙、41009
        • Servicio de Reumatologia, Hospital Universitario Virgen Macarena

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Main Inclusion Criteria:

  • Male or female patients ≥40 years old.
  • Symptomatic primary knee osteoarthritis (ACR criteria) since ≥6 months prior to screening, Kellgren Lawrence Grade 2 or 3, and representing an indication for intra-articular drug injection.
  • >50 mm VAS pain score assigned to the index knee at WOMAC VA 3.1-A1 (pain while walking on a flat surface).
  • >125 mm VAS pain score assigned to the index knee at WOMAC VA 3.1 A subscore (total pain).
  • Pain in the index knee on at least 50% of the days in the month preceding the screening.

Main Exclusion Criteria:

  • Patients with Kellgren & Lawrence Grade I or IV (doubtful or severe) osteoarthritis of the knee.
  • Knee condition representing an indication for surgery
  • Patients with Inflammatory or crystal arthropathies, acute fractures, severe loss of bone density, bone necrosis.
  • Patients with isolated patella-femoral syndrome or chondromalacia.
  • Patients with OA predominant in the lateral compartment or any significant valgus deformity.
  • Patients with any other disease or condition interfering with the free use and evaluation of the index knee for the 3 month duration of the trial (e.g. cancer, congenital defects, spine osteoarthritis).
  • Major injury or surgery to the index knee within the previous 12 months prior to screening.
  • Severe hip osteoarthritis ipsilateral to index knee.
  • Any pain >30 mm VAS that could interfere with the assessment of index knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
  • Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation or likely to be changed during the duration of the study
  • Use of systemic or topical corticosteroids >10 mg prednisolone equivalent per day during 30 days prior to randomisation.
  • Use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics) during 1 or 2 weeks prior to randomisation.
  • Any intra-articular or local periarticular punction, injection or surgery to the index knee during the 6 months prior to screening.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Double dose MEN16132 0.125 mg
Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval.
药品：MEN16132 - 0.125 mg
Intra-articular administration of two low doses of MEN16132 at 2-week interval.
其他名称：
  • fasitibant 0.125 mg
实验性的：Double dose MEN16132 0.25 mg
Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval.
药品：MEN16132 - 0.25 mg
Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
其他名称：
  • fasitibant 0.25 mg
实验性的：Double dose MEN16132 0.5 mg
Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval.
药品：MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
其他名称：
  • fasitibant 0.5 mg
药品：MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
其他名称：
  • fasitibant 0.5 mg
实验性的：Single dose MEN16132 0.5 mg
Intra-articular administration of one 0.5 mg dose of MEN16132 followed by one intra-articular injection of placebo at 2-week interval.
药品：MEN16132 - 0.5 mg
Intra-articular injection of two high doses of MEN16132 at 2-week interval
其他名称：
  • fasitibant 0.5 mg
药品：MEN16132 - 0.5 mg
Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
其他名称：
  • fasitibant 0.5 mg
安慰剂比较：Placebo
Intra-articular administration of two doses of Placebo at 2-week interval.
药品：Placebo
Intra-articular injection of 2 doses of Placebo control at 2-week interval

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
WOMAC VA 3.1 A Score (Total Pain)
大体时间：over the 3 weeks after the first administration

Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain , range 0-500 mm) is the sum of VAS scores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours.

The higher is the WOMAC VA 3.1 A score, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain).

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.

The change from baseline was assessed along 3 weeks after first drug administrations.
over the 3 weeks after the first administration

次要结果测量

结果测量
措施说明
大体时间
WOMAC VA 3.1.B Score (Knee Stiffness)
大体时间：up to 3 months after first dose

WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).

A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness.

The change at Week 13 from baseline is reported.
up to 3 months after first dose
WOMAC VA 3.1. C Score (Function)
大体时间：up to 3 months after first dose

Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours.

The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).

A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities.

WOMAC VA 3.1.C scores at baseline and at Week 13 are reported.
up to 3 months after first dose
Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria
大体时间：up to 3 months after first dose

Osteoarthritis Research Society International (OARSI).

Response defined as:

  • a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale
  • OR if two of the following three findings are recorded:

a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient's global assessment by 20% or more and by 10 or more points on the scale.
up to 3 months after first dose
Patient Global Assessment
大体时间：up to 3 months after first dose

Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm).

Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0).

A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms.
up to 3 months after first dose
WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]
大体时间：over the 3 weeks after the first administration

Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
over the 3 weeks after the first administration
WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]
大体时间：over the 3 weeks after the first administration

Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported.

A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
over the 3 weeks after the first administration
Adverse Event Reports
大体时间：up to 4 months after screening
Incidence of spontaneously reported adverse events
up to 4 months after screening
Clinically Significant Abnormal Laboratory Tests
大体时间：up to 4 months from screening

Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators.

The following hematochemical and urinary parameters were analysed:

Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin.
up to 4 months from screening

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Menarini Group

调查人员

  • 首席研究员：Karel Pavelka, Prof MD、Institute of Rheumatology, Charles University Prague

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年3月1日

初级完成 (实际的)

2011年2月1日

研究完成 (实际的)

2011年3月1日

研究注册日期

首次提交

2010年3月18日

首先提交符合 QC 标准的

2010年3月19日

首次发布 (估计)

2010年3月23日

研究记录更新

最后更新发布 (估计)

2013年2月18日

上次提交的符合 QC 标准的更新

2013年1月16日

最后验证

2013年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BKOS-02
  • 2009-014918-99 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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