4318-0011_RIVER
Research type
Research Study
Full 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
IRAS ID
1008039
Contact name
Katherine Takaki
Contact email
Sponsor organisation
Trevi Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Refractory chronic cough (RCC) is a cough that lasts for longer than 8 weeks even after patients are treated for the underlying condition causing the cough. Most RCC patients report that available off-label treatments have limited to no effect on their cough.
This research study will evaluate the safety and effectiveness of nalbuphine extended-release tablets (NAL ER) for the treatment of RCC. The active ingredient in NAL ER is nalbuphine, which binds to ĸ- and µ-opioid receptors that are found in the brain and in the lungs and may play a role in the cough reflex. In a previous study in patients who had cough associated with idiopathic pulmonary fibrosis, NAL ER reduced daytime cough compared to placebo treatment (a tablet that contains no active ingredients).
The current study is a Phase 2, proof-of-concept study in patients with RCC. NAL ER will be compared to placebo using a 2-period, cross-over design. This means that all participants will receive NAL ER treatment in one part of the study and treatment with placebo in the other part of the study. This ensures that all participants will have access to the possible benefit of the experimental treatment. However, neither the doctors nor the patients will know whether the experimental treatment is given in period 1 or period 2. Each treatment period lasts for 21 days with a 21-day washout period in between treatment periods.
Approximately 60 participants are planned across 12-16 study sites in Canada and the UK.
To study the effectiveness of NAL ER, participants will wear a cough monitor for a period of 24 hours at different times during the study. Other study procedures include: the completion of questionnaires and safety assessments (physical examination, blood and urine tests, chest x-ray, spirometry, and ECGs to measure the electrical activity of the heart).REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0306
Date of REC Opinion
17 Nov 2023
REC opinion
Further Information Favourable Opinion