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Opioid Analgesic

NAL ER for Chronic Cough (RIVER 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

Chest radiograph or CT of thorax within 24 months or during screening not demonstrating any significant abnormalities contributing to RCC

Diagnosis of refractory chronic cough (RCC) for at least one year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 7, 14, and 21 versus baseline

Awards & highlights

RIVER Trial Summary

This trial is studying a medication called Nalbuphine ER (NAL ER) to treat cough in patients with Refractory Chronic Cough. The study is divided into two periods, each

Who is the study for?

This trial is for people who have had a persistent cough that doesn't respond to treatment (refractory chronic cough) for at least one year. They should not have any significant chest abnormalities on recent imaging tests.Check my eligibility

What is being tested?

The study is testing Nalbuphine ER, a medication, against a placebo in two 21-day periods with a break in between. Participants will receive either the medication or placebo first and then switch to the other after the break.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include drowsiness, dizziness, nausea, dry mouth, or sweating. Side effects can vary from person to person.

RIVER Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My recent chest scans show no major issues related to kidney cancer.

Select...

I have had a chronic cough for over a year that doesn’t respond to treatment.

RIVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 7, 14, and 21 versus baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 7, 14, and 21 versus baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 7, 14, and 21 versus baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

24 hr cough frequency

Secondary outcome measures

24 hour cough frequency

Awake cough frequency

Clinicians Global Impression of Cough Change

+10 more

Side effects data

From 2015 Phase 2 & 3 trial • 373 Patients • NCT02143648

Cardiac failure congestive

Diarrhoea

Hyperkalemia

Fluid overload

Transient ischemic attack

Non-cardiac chest pain

Vertigo

Arteriovenous fistula site complication

Conversion disorder

100%

80%

60%

40%

20%

Study treatment Arm

Nalbuphine HCl ER 120mg

Nalbuphine HCl ER 60mg

Sugar Pill

RIVER Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NAL ERExperimental Treatment1 Intervention

NAL ER, tablets, 27 mg QD to BID, 54 mg BID, 108 mg BID

Group II: PlaceboPlacebo Group1 Intervention

Placebo, tablets, 0 mg QD to BID, 0 mg BID, 0 mg BID

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trevi TherapeuticsLead Sponsor

10 Previous Clinical Trials

1,327 Total Patients Enrolled

David Clark, MDStudy DirectorTrevi Therapeutics

4 Previous Clinical Trials

620 Total Patients Enrolled

Frequently Asked Questions

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

At present, how many locations are hosting this particular clinical trial?

"Inspiration Research in Toronto, Belfast City Hospital in Belfast, and Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital in Cottingham are among the 14 locations currently enrolling patients for this clinical trial."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the information available on clinicaltrials.gov affirms that this particular clinical trial is presently enrolling participants. The initial posting of the trial occurred on November 30th, 2023, and it was most recently edited on December 21st, 2023. The study aims to recruit a total of 60 individuals distributed among fourteen different sites."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, the information available on clinicaltrials.gov indicates that this clinical trial is currently actively seeking eligible participants. The study was originally posted on November 30th, 2023 and has been recently updated as of December 21st, 2023. A total of 60 patients are being sought across a network of 14 designated sites."

Answered by AI

Has the NAL ER medication received official approval from the FDA?

"Based on our evaluation, the safety of NAL ER is rated as 2 according to Power's scale. This assessment is due to the fact that this trial falls under Phase 2, where there exists limited data supporting safety but no evidence yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Refractory Chronic Cough Improvement Via NAL ER (RIVER)

2023. "Refractory Chronic Cough Improvement Via NAL ER (RIVER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05962151.