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NCT01697956 · ClinicalTrials.gov registry record · Phase 3

Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)

A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
99
Enrollment target

NCT01697956: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT01697956 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 99 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01697956, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
99 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.

Primary Outcome

The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.

Interventions

  • DRUG Placebo
  • DRUG BDP

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2012-10
Est. Completion 2013-02
Phase Phase 3

What the finished NCT01697956 record still lists

NCT01697956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01697956 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01697956 about?

NCT01697956 is a clinical study titled "Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)". The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to...

What is the current status of trial NCT01697956?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2012-10. Estimated completion is 2013-02.

What interventions are being tested in trial NCT01697956?

The interventions under investigation include: Placebo (DRUG), BDP (DRUG).

Who is sponsoring clinical trial NCT01697956?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01697956's enrollment target sits among peer trials

99 1713th of 2000 higher than 287 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 NCT01697956, the US trial registry maintained by the National Library of Medicine. NCT01697956 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.