盐酸阿米替林/盐酸羟甲唑啉/酮洛芬(Amitriptyline hydrochloride/Oxymetazoline Hydrochloride/Ketoprofen)

概要

基本信息

药物类型

小分子化药

别名

Amitriptyline/oxymetazoline/ketoprofen、Ketoprofen/amitriptyline/oxymetazoline、Ketoprofen/oxymetazoline/amitriptyline

+ [5]

靶点

MATs x α1A-AR

作用机制

单胺再摄取抑制剂、α1A-AR拮抗剂(肾上腺素能受体α-1a拮抗剂)

治疗领域

神经系统疾病其他疾病

在研适应症-

非在研适应症

前交叉韧带损伤膝盖受伤撕裂+ [1]

原研机构

Omeros Corp.

在研机构-

非在研机构

Omeros Corp.

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C16H25ClN2O

InChIKeyBEEDODBODQVSIM-UHFFFAOYSA-N

CAS号2315-02-8

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关联

6

项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的临床试验

NCT01406561 / Completed临床3期

A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

The purpose of this study is to assess the effect of OMS103HP solution for Injection (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS) Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms in subjects undergoing meniscectomy.

开始日期2011-08-01

申办/合作机构

Omeros Corp.

EUCTR2010-023888-17-CZ / Unknown statusN/A

A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy

开始日期2011-05-11

申办/合作机构

Omeros Corp.

NCT00624845 / Completed临床2/3期

Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP

The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.

开始日期2007-12-01

申办/合作机构

Omeros Corp.

100 项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的临床结果

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100 项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的转化医学

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100 项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的专利（医药）

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3

项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的文献（医药）

2012-01-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Regarding the Novel Drug OMS103HP

Letter

作者: Mark G. Siegel

2011-08-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery1区 · 医学

Novel Drug OMS103HP Reduces Pain and Improves Joint Motion and Function for 90 Days After Arthroscopic Meniscectomy

1区 · 医学

Article

作者: David L. Fox ; William E. Garrett ; Michael S. Hewitt ; John W. Xerogeanes ; Nebojsa V. Skrepnik ; Neal S. ElAttrache ; J. Steven Whitaker ; Gregory A. Demopulos ; Christopher C. Kaeding ; John D. Papilion ; John B. O'Donnell ; Francis Ruvuna

PURPOSEThis phase 2 study compared OMS103HP (Omeros, Seattle, WA) with control (lactated Ringer's) irrigation solution in patients undergoing arthroscopic partial meniscectomy.METHODSThis was a prospective, multicenter, double-blind, randomized, vehicle-controlled, parallel-group study. Safety and postoperative pain, range of motion, and self-reported function were evaluated for 90 days. Statistical results were based on univariate analysis of variance and repeated-measures analyses.RESULTSMean visual analog scale (VAS) pain scores within 24 hours after discharge from the recovery room showed more pain in the control group beginning at 2 hours and peaking at 8 hours. Univariate analysis of variance of mean VAS scores over the 24-hour period did not meet statistical significance. Repeated-measures analysis yielded a statistically significant difference (P = .004) for time-by-treatment interaction, showing a clear drug benefit over time based on VAS scores. There were statistically significant differences at day 7 between the groups in passive flexion without pain (P = .022). The proportion of patients achieving flexion of 95° or greater, 110°, and 125° was greater for the OMS103HP group. The Knee Injury and Osteoarthritis Outcome Score (KOOS) showed statistically significant differences (P ≤ .05) between the OMS103HP and control groups for 4 of 5 outcomes (symptoms, pain, sport and recreation, and knee-based quality of life but not activities of daily living). All scores showed a treatment effect through day 90. The overall incidence of adverse events and abnormal laboratory values for the OMS103HP and control groups was similar. Serious adverse events occurred in 1 control patient.CONCLUSIONSIn this study of patients with meniscal tears who underwent simple debridement, the use of OMS103HP resulted in reduced acute postoperative pain (measured by VAS over the first 24 hours postoperatively), reduced pain during recovery (measured by the KOOS pain subscale, which measures both background levels of pain and exacerbations caused by movements or activities), improved postoperative knee motion, and improved functional outcomes as assessed with the KOOS Knee Survey. Clinical benefits of OMS103HP were consistent and sustained throughout 90 days of postoperative follow-up.LEVEL OF EVIDENCELevel I, prospective, randomized, controlled trial.

2008-06-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery1区 · 医学

Novel Drug Product to Improve Joint Motion and Function and Reduce Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction

1区 · 医学

Article

作者: Amir M. Khan ; Gail E. Gillenwater ; J. Gregory Perkins ; Gary S. Fanton ; Michael S. Wall ; Gregory A. Demopulos ; Tamara J. Carver ; Michael F. Dillingham

PURPOSEOMS103HP, an investigational drug product containing ketoprofen, amitriptyline, and oxymetazoline, is added to arthroscopic irrigation solution. OMS103HP was evaluated in patients undergoing arthroscopic anterior cruciate ligament reconstruction to assess the drug's safety and ability to improve postoperative knee function and motion, reduce postoperative pain, and allow earlier return to work.METHODSThis was a prospective, double-blind, vehicle-controlled, parallel-group, randomized study. Allograft anterior cruciate ligament reconstruction patients in both treatment and vehicle control groups were monitored for safety and efficacy (e.g., measurements of knee function and motion, pain, and return to work) over a 30-day postoperative period. The efficacy endpoints of primary interest were assessed by use of both responder and time-to-event analyses.RESULTSThere were statistically significant differences (P < or = .05) between the OMS103HP and vehicle control groups in the endpoints of knee function (knee function composite and straight-leg raise component of knee function composite), range of motion (median number of days to maximum passive flexion of 90 degrees or greater without pain and time to discontinuation of continuous passive motion), quadriceps and hamstring muscle strength, successful pain management, and return to work. The overall incidences of adverse events and abnormal clinical laboratory values for both OMS103HP- and vehicle-treated subjects were similar, and none was attributed to OMS103HP.CONCLUSIONSThe clinical benefits of OMS103HP in this study were reduced postoperative pain; improved postoperative knee motion, quadriceps and hamstring muscle strength, and knee function; and earlier return to work as measured by surgeons, nurses, and physical therapists across repeated clinic visits and rehabilitation sessions and recorded by patients in daily diaries. The drug was well tolerated.

100 项与盐酸阿米替林/盐酸羟甲唑啉/酮洛芬相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
撕裂	临床3期	美国	Omeros Corp.	2011-08-01
术后疼痛	临床3期	美国	Omeros Corp.	2007-12-01
膝盖受伤	临床3期	加拿大	Omeros Corp.	2004-11-01
前交叉韧带损伤	临床3期	美国	Omeros Corp.	2004-10-01