Trials / Completed
CompletedNCT05964335
Cough Reduction in IPF With Nalbuphine ER
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Trevi Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of the study is to evaluate the effect of NAL ER on 24-hour cough frequency using objective digital cough monitoring and to assess safety and tolerability of NAL ER.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NAL ER | Oral tablets |
| DRUG | Placebo | Oral tablets |
| DRUG | NAL ER | Oral Tablets |
| DRUG | NAL ER | Oral tablets |
Timeline
- Start date
- 2024-02-06
- Primary completion
- 2025-04-24
- Completion
- 2025-04-24
- First posted
- 2023-07-27
- Last updated
- 2025-06-27
Locations
59 sites across 10 countries: Australia, Canada, Chile, Germany, Italy, Netherlands, Poland, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05964335. Inclusion in this directory is not an endorsement.