Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-07-07
Brief Title:
Refractory Chronic Cough Improvement Via NAL ER RIVER
Sponsor:
Trevi Therapeutics
Organization:
Trevi Therapeutics
Study Overview
Official Title:
A Phase 2 Double-Blind Randomized Placebo-Controlled Two-Period Crossover Efficacy and Safety Study of Nalbuphine ER Tablets for the Treatment of Refractory Chronic Cough
Status:
ACTIVE_NOT_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:
RIVER
Brief Summary:
A 2-period crossover study for the treatment of cough in patients with Refractory Chronic Cough via Nalbuphine ER NAL ER Each period will last 21 days and are separated by 21 days Subjects will be randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluated for 21 days After completion of the first phase subjects who received NAL ER will crossover to placebo and subjects who received placebo will crossover to NAL ER to complete Treatment Period 2
For more information see the approved website TheRiverTrialcom
For more information see the approved website TheRiverTrialcom
Detailed Description:
A double-blind randomized placebo-controlled 2-period crossover study for the treatment of cough with NAL ER in subjects with Refractory Chronic Cough
Based on the screening cough monitor results the study will enroll subjects in a 11 ratio to subgroups of 10-19 coughshour and 20 coughshour
After meeting eligibility during the screening period subjects will be randomly assigned to one of the following sequences
NAL ER in Treatment Period 1 followed by Placebo PBO in Treatment Period 2 OR
PBO in Treatment Period 1 followed by NAL ER in Treatment Period 2
Each treatment period lasts 21 days and are separated by a 21-day washout period Subjects on NAL ER will have the dose titrated from 27 mg once a day QD to 108 mg twice a day BID
Study visits in each treatment period will be at Day -1 for Baseline cough assessments and at Days 6 13 and 20 Subjects will have blood drawn for pharmacokinetic PK analysis of nalbuphine plasma concentration Subjects will also complete questionnaires for efficacy evaluations and undergo safety evaluations including an electrocardiogram ECG
At the Screening and Baseline visits and on Days 6 13 and 20 during each treatment period site staff will place an electronic cough monitor on the subject which will be worn for a 24-hour recording period to assess cough frequency At the end of each recording session Days 7 14 and 21 the monitor will be removed at home by the subject and the subjects will complete Patient Reported Outcomes PROs questionnaires in the electronic diary
Subjects will be taken off study drug at the end of Treatment Period 2 and followed off treatment for an additional 2 weeks
Based on the screening cough monitor results the study will enroll subjects in a 11 ratio to subgroups of 10-19 coughshour and 20 coughshour
After meeting eligibility during the screening period subjects will be randomly assigned to one of the following sequences
NAL ER in Treatment Period 1 followed by Placebo PBO in Treatment Period 2 OR
PBO in Treatment Period 1 followed by NAL ER in Treatment Period 2
Each treatment period lasts 21 days and are separated by a 21-day washout period Subjects on NAL ER will have the dose titrated from 27 mg once a day QD to 108 mg twice a day BID
Study visits in each treatment period will be at Day -1 for Baseline cough assessments and at Days 6 13 and 20 Subjects will have blood drawn for pharmacokinetic PK analysis of nalbuphine plasma concentration Subjects will also complete questionnaires for efficacy evaluations and undergo safety evaluations including an electrocardiogram ECG
At the Screening and Baseline visits and on Days 6 13 and 20 during each treatment period site staff will place an electronic cough monitor on the subject which will be worn for a 24-hour recording period to assess cough frequency At the end of each recording session Days 7 14 and 21 the monitor will be removed at home by the subject and the subjects will complete Patient Reported Outcomes PROs questionnaires in the electronic diary
Subjects will be taken off study drug at the end of Treatment Period 2 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