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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 is a Phase 2 study that has completed, run by Ono Pharma USA. The registered enrollment target is 59 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01536041
The ClinicalTrials.gov registry entry for NCT01536041 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ono Pharma USA, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01536041 reports 0 study locations.
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.
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