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NCT00953147 · ClinicalTrials.gov registry record · Phase 3

A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
1,110
Enrollment target

NCT00953147: Completed Phase 3 study, sponsored by Sumitomo Pharma America.

NCT00953147 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 1,110 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00953147, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
1,110 participants
Enrollment target

Study Summary

This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

Primary Outcome

TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1. = mild 2. = moderate 3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baselin

Interventions

  • DRUG Placebo
  • DRUG Ciclesonide HFA 80 mcg
  • DRUG Ciclesonide HFA 160 mcg

Trial Details

FieldValue
Enrollment Target 1,110 participants
Start Date 2009-08
Est. Completion 2010-05
Phase Phase 3
Sumitomo Pharma America

168 total trials

What the finished NCT00953147 record still lists

NCT00953147 is an interventional study that assigns participants to a tested intervention. Its 1,110 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% higher).

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

NCT00953147 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00953147 about?

NCT00953147 is a clinical study titled "A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older". This is a 6-month multi-center, randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of ciclesonide HFA nasal aerosol administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR).

What is the current status of trial NCT00953147?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,110 participants. The study started on 2009-08. Estimated completion is 2010-05.

What interventions are being tested in trial NCT00953147?

The interventions under investigation include: Placebo (DRUG), Ciclesonide HFA 80 mcg (DRUG), Ciclesonide HFA 160 mcg (DRUG).

Who is sponsoring clinical trial NCT00953147?

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

How this trial's enrollment target compares

Where NCT00953147's enrollment target sits among peer trials

1,110 251st of 2000 higher than 1,750 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00953147, the US trial registry maintained by the National Library of Medicine. NCT00953147 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.