Refractory Chronic Cough Improvement Via NAL ER (RIVER) (NCT05962151) | Clinical Trial Compass
CompletedPhase 2
Refractory Chronic Cough Improvement Via NAL ER (RIVER)
Canada, United Kingdom66 participantsStarted 2023-11-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Diagnosis of refractory chronic cough (RCC) for at least one year
* Chest radiograph or CT of thorax within 24 months or during screening not demonstrating any significant abnormalities contributing to RCC
Exclusion Criteria:
* Diagnosis of sleep apnea
* Respiratory tract infection within 6 weeks of Baseline
* History of bronchiectasis, COPD, or IPF
* History of uncontrolled asthma
* Current smokers/vapers, quit smoking with \<=12 months, using nicotine supplements, or history of \>=20 pack years
* History of major psychiatric disorder
* History of substance abuse
* Pregnant or lactating females
* Known intolerance to opioids
* Abnormal kidney or liver functions based on Screening lab results.
* Known hypersensitivity to nalbuphine or to NAL ER excipients
* Previous participation in a nalbuphine ER clinical study
* Use of opiates, benzodiazepines, or MAOIs within 14 days of Baseline
* Use of pregabalin, gabapentin, thalidomide for treatment of cough within 14 days of Baseline
* Use of ACE inhibitors within 12 weeks of Baseline
* Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline
* Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.
* Use of unstable doses of cough suppressants within 14 days of Baseline
* Use of unstable doses of medications …
What they're measuring
1
Relative Change From Baseline in 24-hour Cough Frequency at Day 21