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NCT01536041 · ClinicalTrials.gov registry record · Phase 2
A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients
A Phase 2 study, sponsored by Ono Pharma USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT01536041: Completed Phase 2 study, sponsored by Ono Pharma USA.
NCT01536041 is a Phase 2 study that has completed, run by Ono Pharma USA. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01536041, a Phase 2 study, has completed, sponsored by Ono Pharma USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
The primary objectives of this study are: i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. to determine the safety and tolerability of single dose administrations of 20 and 200 mg of ONO-6950 in asthmatic patients. The secondary objectives of this study are: i. to compare the effect of different (20 and 200 mg) single oral doses of ONO-6950 versus montelukast (10 mg) on EIB as percent attenuation in the decrease of FEV1 after exercise challenge ii. to determine the ratio of responders/non-responders in FEV1 for different (20 and 200 mg) single oral doses of ONO-6950 in comparison to montelukast (10 mg) and placebo.
Interventions
- DRUG Placebo
- DRUG Montelukast
- DRUG ONO-6950
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01536041 record still lists
NCT01536041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01536041 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01536041 about?
NCT01536041 is a clinical study titled "A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients". The primary objectives of this study are: i. to determine the effect of single oral doses (20 and 200 mg) of ONO-6950 versus placebo on exercise induced bronchoconstriction (EIB) as percent attenuation in the decrease of forced expiratory volume in 1 second (FEV1) after exercise challenge ii. to d...
What is the current status of trial NCT01536041?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2012-03.
What interventions are being tested in trial NCT01536041?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG), ONO-6950 (DRUG).
Who is sponsoring clinical trial NCT01536041?
This trial is sponsored by Ono Pharma USA, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01536041's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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