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Opioid Analgesic

NAL ER 108 mg for Idiopathic Pulmonary Fibrosis (CORAL Trial)

Phase 2

Recruiting

Research Sponsored by Trevi Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines

FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 3, 4, 5, 6

Awards & highlights

CORAL Trial Summary

This trial is testing a drug called nalbuphine ER in different doses to see its effect on participants. Participants will be randomly assigned to one of four groups: one will receive a placebo,

Who is the study for?

This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF) who have a chronic cough and meet specific lung function criteria, including a Cough Severity Score of at least 4, oxygen saturation levels above 92%, and certain capacities in diffusing carbon monoxide and forced vital capacity. It's not suitable for those who don't meet these lung function thresholds.Check my eligibility

What is being tested?

The study tests the effectiveness of three different doses of nalbuphine ER (27 mg, 54 mg, and 108 mg) compared to a placebo in reducing cough due to IPF. Participants are randomly assigned to one of four groups and will take their assigned treatment over six weeks after an initial titration period.See study design

What are the potential side effects?

While the side effects aren't specified here, nalbuphine ER may cause dizziness, nausea, dry mouth or sweating. Side effects can vary based on dosage; higher doses typically increase the likelihood of experiencing them.

CORAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with IPF by a specialist.

Select...

My lung function test shows at least 40% of normal capacity.

Select...

My cough is severe, scoring 4 or more on a scale.

Select...

I have had a chronic cough for at least 8 weeks.

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My lung's ability to transfer gas is at least 25% of what is expected.

CORAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 3, 4, 5, 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 3, 4, 5, 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 4, 5, 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of NAL ER on 24-hour cough frequency (coughs per hour)

Secondary outcome measures

24-hour cough frequency (Coughs per hour)

Awake cough frequency (Coughs per hour)

CGI-C

+14 more

CORAL Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NAL ER 54 mgExperimental Treatment1 Intervention

BID

Group II: NAL ER 27 mgExperimental Treatment1 Intervention

BID

Group III: NAL ER 108 mgExperimental Treatment1 Intervention

BID

Group IV: PlaceboPlacebo Group1 Intervention

Placebo, tablets BID

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor

10 Previous Clinical Trials

1,227 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

42 Patients Enrolled for Idiopathic Pulmonary Fibrosis

David Clark, MDStudy DirectorTrevi Therapeutics

4 Previous Clinical Trials

520 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enlist additional participants for this medical study?

"Following the latest data on clinicaltrials.gov, this particular medical investigation is actively seeking suitable candidates. Originally shared on 2/6/2024, it was last revised on 2/7/2024."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"Currently, there are 64 active enrollment sites for this trial spread across various regions such as Heidelberg, Kent Town, and Windsor among others. Choosing a location in proximity to you may reduce the burden of travel during your participation."

Answered by AI

What is the safety profile of NAL ER 54 mg for individuals?

"Based on our evaluation at Power, the safety rating for NAL ER 54 mg is a level 2. This assessment stems from it being in Phase 2 of clinical testing, signifying partial safety data availability with no evidence backing efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cough Reduction in IPF With Nalbuphine ER

2024. "Cough Reduction in IPF With Nalbuphine ER". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05964335.

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