Cough Reduction in IPF With Nalbuphine ER — CORAL  

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)

Status Recruiting

Clinical Trial Summary

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER).

After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

• Arm 1: Placebo

• Arm 2: 27 mg nalbuphine ER

• Arm 3: 54 mg nalbuphine ER

• Arm 4: 108 mg nalbuphine ER

Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

Clinical Trial Description

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study.

After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

• Arm 1: Placebo

• Arm 2: 27 mg nalbuphine ER

• Arm 3: 54 mg nalbuphine ER

• Arm 4: 108 mg nalbuphine ER

Each arm will be titrated to their fixed dose during the blinded 2-week Titration period according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off treatment for an additional 2 weeks. ;

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT05964335
• Study type: Interventional
• Source: Trevi Therapeutics
• Contact: Beata Dworakowska
• Phone: 203-654-3284
• Email: Beata.Dworakowska@trevitherapeutics.com
• Status: Recruiting
• Phase: Phase 2
• Start date: February 6, 2024
• Completion date: October 14, 2024