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NCT01451541 · ClinicalTrials.gov registry record · Phase 3

A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
848
Enrollment target

NCT01451541 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 848 participants.

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The verdict

NCT01451541, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
848 participants
Enrollment target

Study Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Interventions

  • DRUG Placebo
  • DRUG Ciclesonide nasal aerosol 37 mcg
  • DRUG ciclesonide nasal aerosol 74 mcg

Trial Details

FieldValue
Enrollment Target 848 participants
Start Date 2011-10
Est. Completion 2012-12
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT01451541

The ClinicalTrials.gov registry entry for NCT01451541 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 848 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01451541 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01451541 about?

NCT01451541 is a clinical study titled "A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).". This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of ciclesonide nasal aerosol administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

What is the current status of trial NCT01451541?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 848 participants. The study started on 2011-10. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01451541?

The interventions under investigation include: Placebo (DRUG), Ciclesonide nasal aerosol 37 mcg (DRUG), ciclesonide nasal aerosol 74 mcg (DRUG).

Who is sponsoring clinical trial NCT01451541?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.