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NCT00305487 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

A Phase 3 study of Seasonal Allergic Rhinitis and Hay Fever, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
660
Enrollment target
20
Study locations

NCT00305487 is a Phase 3 study of Seasonal Allergic Rhinitis and Hay Fever that has completed, run by AstraZeneca. The registered enrollment target is 660 participants, roughly in line with the 627-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT00305487, a Phase 3 study of Seasonal Allergic Rhinitis and Hay Fever, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
660 participants
Enrollment target
20
Study locations

Study Summary

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

Interventions

  • DRUG Ciclesonide nasal spray

Study Locations (20)

California

  • Altana Pharma/Nycomed - Costa Mesa
  • Altana Pharma/Nycomed - Huntington Beach
  • Altana Pharma/Nycomed - Long Beach
  • Altana Pharma/Nycomed - Los Alamitos
  • Altana Pharma/Nycomed - Mission Viejo
  • Altana Pharma/Nycomed - Orange
  • Altana Pharma/Nycomed - Roseville
  • Altana Pharma/Nycomed - San Diego
  • Altana Pharma/Nycomed - San Diego
  • Altana Pharma/Nycomed - San Jose
  • Altana Pharma/Nycomed - Stockton

Colorado

  • Altana Pharma/Nycomed - Colorado Springs
  • Altana Pharma/Nycomed - Denver
  • Altana Pharma/Nycomed - Englewood
  • Altana Pharma/Nycomed - Lakewood, CO

Georgia

  • Altana Pharma/Nycomed - Atlanta
  • Altana Pharma/Nycomed - Gainesville
  • Altana Pharma/Nycomed - Savannah

Alabama

  • Altana Pharma/Nycomed - Birmingham

Arkansas

  • Altana Pharma/Nycomed - Hot Springs

Trial Details

FieldValue
Enrollment Target 660 participants
Start Date 2006-03
Est. Completion 2006-10
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00305487

The ClinicalTrials.gov registry entry for NCT00305487 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 660 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 627-participant average among 16 other Seasonal Allergic Rhinitis trials with a reported enrollment target. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Seasonal Allergic Rhinitis appearing as the primary indexed condition, and to 1 intervention - of which Ciclesonide nasal spray is the first listed.

NCT00305487 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Georgia.

Frequently Asked Questions

What is clinical trial NCT00305487 about?

NCT00305487 is a clinical study titled "Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)". The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

What is the current status of trial NCT00305487?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2006-03. Estimated completion is 2006-10.

What conditions does trial NCT00305487 study?

This clinical trial studies the following conditions: Seasonal Allergic Rhinitis, Hay Fever.

What interventions are being tested in trial NCT00305487?

The interventions under investigation include: Ciclesonide nasal spray (DRUG).

Who is sponsoring clinical trial NCT00305487?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00305487 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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