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NCT01378429 · ClinicalTrials.gov registry record · Phase 3

Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
89
Enrollment target

NCT01378429 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 89 participants.

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The verdict

NCT01378429, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
89 participants
Enrollment target

Study Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when 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

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2011-07
Est. Completion 2011-11
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT01378429

The ClinicalTrials.gov registry entry for NCT01378429 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 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 2 interventions - of which Placebo is the first listed.

NCT01378429 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01378429 about?

NCT01378429 is a clinical study titled "Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis". This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when 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 NCT01378429?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2011-07. Estimated completion is 2011-11.

What interventions are being tested in trial NCT01378429?

The interventions under investigation include: Placebo (DRUG), ciclesonide nasal aerosol (DRUG).

Who is sponsoring clinical trial NCT01378429?

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.