Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964335
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-07-07
Brief Title:
Cough Reduction in IPF with Nalbuphine ER
Sponsor:
Trevi Therapeutics
Organization:
Trevi Therapeutics
Study Overview
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORAL
Brief 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 1111 to one of four treatment arms with placebo and increasing doses of 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
For more information see the country specific approved websites
Germany Netherlands Poland Spain Italy Chile TheCoralTrialcom United Kingdom Australia Canada CoralCoughTrialcom Turkey please refer to the list of locations and reach out to the site directly
After meeting eligibility during the Screening Period subjects will be randomized 1111 to one of four treatment arms with placebo and increasing doses of 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
For more information see the country specific approved websites
Germany Netherlands Poland Spain Italy Chile TheCoralTrialcom United Kingdom Australia Canada CoralCoughTrialcom Turkey please refer to the list of locations and reach out to the site directly
Detailed 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 1111 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
After meeting eligibility during the Screening Period subjects will be randomized 1111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None