Promethazine/hydrocodone/paracetamol(Promethazine/hydrocodone/paracetamol) - 药物靶点：COX-2 x H1 receptor x Opioid receptors_专利_临床

概要

基本信息

药物类型

小分子化药

别名

靶点

COX-2 x H1 receptor x Opioid receptors

作用机制

COX-2抑制剂(环氧化酶-2抑制剂)、H1 receptor拮抗剂(组胺H1受体拮抗剂)、Opioid receptors激动剂(阿片样受体激动剂)

治疗领域

神经系统疾病其他疾病免疫系统疾病+ [1]

在研适应症-

非在研适应症

急性疼痛药物引起的恶心和呕吐恶心+ [4]

原研机构

Charleston Laboratories, Inc.

在研机构-

非在研机构

Charleston Laboratories, Inc.

最高研发阶段无进展申请上市

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C17H21ClN2S

InChIKeyXXPDBLUZJRXNNZ-UHFFFAOYSA-N

CAS号58-33-3

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关联

4

项与 Promethazine/hydrocodone/paracetamol 相关的临床试验

NCT02712554 / Completed临床1期

A Randomized, Double-Blind, Placebo and Active-Controlled, Crossover Study in Opioid-Experienced, Non-Dependent Recreational Drug Users to Determine the Abuse Potential and Safety of CL-108 Tablets Administered Via the Oral Route

The purpose of this study is to assess the abuse potential of CL-108 tablets, including the abuse deterrent effects of promethazine, following oral administration, relative to hydrocodone/acetaminophen (APAP) tablets and placebo in non-dependent, recreational opioid users.

开始日期2015-06-01

申办/合作机构

Charleston Laboratories, Inc.

NCT02465866 / Completed临床1期

A Single-Dose, Four-Period, Four-Treatment, Four-Way Crossover Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions

This study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in CL-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by Charleston Laboratories, Inc. to hydrocodone in Vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in Ultracet (tramadol HCl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.

开始日期2014-11-01

申办/合作机构

Charleston Laboratories, Inc.

NCT02462850 / Completed临床3期

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

The purpose of CLCT-006, a multi-center open-label study, is to evaluate the safety of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) for the treatment of moderate to severe acute pain ("flare") associated with osteoarthritis of the knee or hip under actual conditions of use.

开始日期2014-10-01

申办/合作机构

Charleston Laboratories, Inc.

100 项与 Promethazine/hydrocodone/paracetamol 相关的临床结果

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100 项与 Promethazine/hydrocodone/paracetamol 相关的转化医学

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100 项与 Promethazine/hydrocodone/paracetamol 相关的专利（医药）

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5

项与 Promethazine/hydrocodone/paracetamol 相关的文献（医药）

2019-12-01·Pain Medicine3区 · 医学

Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg

3区 · 医学

Article

作者: Granquist, Eric J ; Zuniga, John R ; Muse, Derek D ; Giannakopoulos, Helen E ; Levin, Lawrence M ; Oreadi, Daniel ; Maibach, Hilda ; Schachtel, Bernard P ; Papas, Athena S ; Chou, Joli C ; Patrick, Kyle ; Daniels, Stephen E

AbstractObjectivesTo evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used.MethodsThis was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24).ResultsRelative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events.ConclusionsCL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.

2016-06-01·The Journal of Pain

Erratum to (440) Opioid-Induced Nausea and Vomiting (OINV) in Post-Operative Patients: A Comparison of CL-108 to Hydrocodone 7.5 mg/Acetaminophen 325 mg

2016-06-01·The Journal of Pain

Erratum to (438) Efficacy of CL-108 Compared to Hydrocodone 7.5 mg/Acetaminophen 325 mg in Preventing Vomiting and the Use of Anti-Emetics, Opioid-Induced Nausea and Vomiting (OINV)

100 项与 Promethazine/hydrocodone/paracetamol 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
急性疼痛	申请上市	美国	Charleston Laboratories, Inc.	2016-03-31
恶心和呕吐	申请上市	美国	Charleston Laboratories, Inc.	2016-03-31
疼痛	申请上市	-	Charleston Laboratories, Inc.	2015-06-01
膝关节炎	申请上市	美国	Charleston Laboratories, Inc.	2014-10-01
药物引起的恶心和呕吐	申请上市	美国	Charleston Laboratories, Inc.	2014-09-01
恶心	申请上市	美国	Charleston Laboratories, Inc.	2014-09-01
呕吐	临床2期	美国	Charleston Laboratories, Inc.	2014-09-01