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Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets (OCEAN-2)

2026年11月12日 更新者：Trevi Therapeutics

A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

201

阶段

  • 第三阶段

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。

学习联系方式

学习地点

  • 美国
    • Alabama
      • Tuscaloosa、Alabama、美国、35476
        • 招聘中
        • Sec Clinical Research - Dothan
    • Connecticut
      • New Britain、Connecticut、美国、06051
        • 招聘中
        • Starling Physicians, P.C.
    • Delaware
      • Wilmington、Delaware、美国、19803
        • 招聘中
        • Premier Medical Associates, LLC
    • Florida
      • Doral、Florida、美国、33122
        • 招聘中
        • D&H Doral Research Center
      • Miami、Florida、美国、33186
        • 招聘中
        • Coral Research Clinic Corp.
      • Miami、Florida、美国、33173
        • 招聘中
        • Blessed Health Care and Research Inc.
      • Miami Lakes、Florida、美国、33016
        • 招聘中
        • Pharma Medical Innovations, Inc.
      • North Miami Beach、Florida、美国、33162
        • 招聘中
        • Essential Health and Research Services
    • Maryland
      • Rockville、Maryland、美国、20854
        • 招聘中
        • Velocity Clinical Research - Rockville
    • Michigan
      • Allen Park、Michigan、美国、48101
        • 招聘中
        • Vitalis Clinical Research Center LLC
    • Missouri
      • Warren、Missouri、美国、48071
        • 招聘中
        • Veritas Clinical Research
    • North Carolina
      • Charlotte、North Carolina、美国、28277
        • 招聘中
        • American Health Research - Charlotte Location
    • Oregon
      • Bend、Oregon、美国、97701
        • 招聘中
        • Summit Health (Summit Medical Group) - Eastside Clinic
      • Portland、Oregon、美国、97220
        • 招聘中
        • The Oregon Clinic - Gateway Medical Office Location - Pulmonary, Critical Care & Sleep Medicine East
    • Texas
      • Carrollton、Texas、美国、75010
        • 招聘中
        • Stryde Research
      • Sugar Land、Texas、美国、77478
        • 招聘中
        • Hillcroft Medical Clinic

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

Inclusion Criteria:

  • Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines.
  • Chronic cough for ≥8 weeks prior to Screening.
  • PGI-Severity Score ≥ 2 at Screening.
  • Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.
  • Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.
  • If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.

Exclusion Criteria:

  • Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.
  • Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 8 weeks prior to Screening.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：NAL ER 54 mg

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 milligrams (mg) twice daily (BID) for 12 weeks.
药品：NAL ER

Oral tablets

其他名称：
  • 纳布啡
安慰剂比较：Placebo

Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks.
药品：Placebo

Oral tablets

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Relative Change from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14

次要结果测量

结果测量
大体时间
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
大体时间：Baseline, Weeks 6 and 10
Baseline, Weeks 6 and 10
Absolute Change from Baseline in 24-hour Cough Frequency for NAL ER Compared With Placebo
大体时间：Baseline, Weeks 6 and 10
Baseline, Weeks 6 and 10
Proportion of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-hour Cough Frequency at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms) at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the CS-NRS for NAL ER Compared With Placebo
大体时间：Baseline up to Week 14
Baseline up to Week 14
Proportion of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS for NAL ER Compared With Placebo
大体时间：Baseline up to Week 14
Baseline up to Week 14
Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social) at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Proportion of Participants Achieving a 1.3-point Increase (Improvement) from Baseline in LCQ Total Score at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Awake Cough Frequency at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Sleep Cough Frequency at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Proportion of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Relative Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) at Week 14 for NAL ER Compared With Placebo
大体时间：Baseline, Week 14
Baseline, Week 14
Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)
大体时间：Baseline up to Week 17
Baseline up to Week 17

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

Trevi Therapeutics

调查人员

  • 研究主任：Chief Development Officer、Trevi Therapeutics, Inc.

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 (实际的)

2026年9月30日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年10月5日

首先提交符合 QC 标准的

2026年10月5日

首次发布 (实际的)

2026年10月9日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月12日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NAL03-302

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

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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