Nalbuphine ER for Chronic Cough

(RIVER Trial)

Recruiting at 15 trial locations

Overseen By Connie Crum, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Trevi Therapeutics

Must not be taking: Opiates, Benzodiazepines, MAOIs, others

Disqualifiers: Sleep apnea, COPD, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to evaluate the effect of NAL ER on 24-hour cough frequency and to assess safety and tolerability of NAL-ER for treatment of refractory chronic cough.

Research Team

Chief Development Officer

Principal Investigator

Trevi Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive NAL ER at escalating doses or placebo

4 weeks

Weekly visits (in-person)

Treatment Period 2

Participants receive placebo or NAL ER at escalating doses

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nalbuphine ER
• Placebo

Trial Overview 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.

Participant Groups

Group I: First Placebo then NAL ER Experimental Treatment 2 Interventions

Participants will receive placebo matched to NAL ER in Treatment Period 1, followed by NAL ER at escalating doses (27 mg QD to BID, 54 mg BID, and 108 mg BID) in Treatment Period 2.

Group II: First NAL ER, then Placebo Experimental Treatment 2 Interventions

Participants will receive NAL ER at escalating doses (27 mg QD to BID, 54 mg BID, and 108 mg BID) in Treatment Period 1, followed by placebo matched to NAL ER in Treatment Period 2.

Nalbuphine ER is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nubain for:

• Moderate to severe pain
• Preoperative and postoperative analgesia
• Obstetrical analgesia during labor and delivery

Approved in European Union as Nalbuphine for:

• Moderate to severe pain
• Preoperative and postoperative analgesia
• Obstetrical analgesia during labor and delivery

Approved in Canada as Nalbuphine for:

• Moderate to severe pain
• Preoperative and postoperative analgesia
• Obstetrical analgesia during labor and delivery

Who Is Running the Clinical Trial?

Trevi Therapeutics

Lead Sponsor

Trials

11

Recruited

1,400+