Principal Investigator: Prof. Lorcan McGarvey                                            

Name of the Study: RIVER
 

Why is this Study important?

The RIVER trial is a double-blind, randomized, placebo-controlled, 2-period crossover study evaluating the safety and efficacy of Nalbuphine ER (NAL ER) Tablets for the Treatment of Refractory Chronic Cough (RCC)

What is the Research question/aim?:  

The primary objective is to evaluate the effect of Nalbuphine on 24-hour cough frequency in patients after 21 days. We aim to evaluate the efficacy, safety and tolerability of Nalbuphine in patients with refractory chronic cough (RCC)

What the Study involves:

There are 3 periods in this study. The first 21 days is called participants will be randomly assigned to either NAL ER or Placebo. After completion of  of this treatment period, participants enter a Washout Period for 21 days where they do not take any study drug. 

Once the 21-day washout period ends participants enter Treatment Period 2. Depending on what participants are initially assigned, they will receive the opposite in Treatment Period 2.  

The study drug dose will slowly increase from 27mg once a day to 108mg twice a day, during the treatment period to allow participants to adjust to the medication. 

Participants have 10 study visits and 2 check-in phone calls during the study.

Who can take part in the Study?

Patients 18 years or older, with a diagnosis of refractory chronic cough (RCC)

Contact Information: 

Sharon Carr
Senior Research Nurse
University Floor
Belfast City Hospital
BT9 7AB
Sharon.carr@belfasttrust.hscni.net

02895 040345