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NCT02503657 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study of Idiopathic Pulmonary Fibrosis and IPF, sponsored by MediciNova.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02503657: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis and IPF, sponsored by MediciNova.
NCT02503657 is a Phase 2 study of Idiopathic Pulmonary Fibrosis and IPF that has completed, run by MediciNova. The registered enrollment target is 15 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02503657, a Phase 2 study of Idiopathic Pulmonary Fibrosis and IPF, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6-month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants were randomly assigned to receive MN-001 or matching placebo twice daily over a 26-week period. A total of 15 participants were enrolled.
Primary Outcome
Predicted forced vital capacity (FVC) is a reference value for lung function based on your age, height, sex, and ethnicity measured by a spirometer and is an established method of pulmonary function. FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters (L).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MN-001
Study Locations (1)
Pennsylvania
- Penn State University College of Medicine, Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2022-03-15 |
| Phase | Phase 2 |
What the finished NCT02503657 record still lists
NCT02503657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02503657 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02503657 about?
NCT02503657 is a clinical study titled "Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis". This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6-month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants were randomly assigned t...
What is the current status of trial NCT02503657?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2016-03-09. Estimated completion is 2022-03-15.
What conditions does trial NCT02503657 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis, IPF.
What interventions are being tested in trial NCT02503657?
The interventions under investigation include: Placebo (DRUG), MN-001 (DRUG).
Who is sponsoring clinical trial NCT02503657?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02503657 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02503657's enrollment target sits among peer trials
15 46th of 51 higher than 5 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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