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NCT01018862 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

A Phase 3 study, sponsored by Meda Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
489
Enrollment target

NCT01018862: Completed Phase 3 study, sponsored by Meda Pharmaceuticals.

NCT01018862 is a Phase 3 study that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 489 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01018862, a Phase 3 study, has completed, sponsored by Meda Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
489 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.

Primary Outcome

Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.

Interventions

  • DRUG Placebo
  • DRUG Azelastine hydrochloride nasal spray 0.15%
  • DRUG Azelastine hydrochloride nasal spray 0.10%

Trial Details

FieldValue
Enrollment Target 489 participants
Start Date 2009-11
Est. Completion 2011-04
Phase Phase 3
Meda Pharmaceuticals

19 total trials

What the finished NCT01018862 record still lists

NCT01018862 is an interventional study that assigns participants to a tested intervention. The registered 489 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).

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

NCT01018862 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01018862 about?

NCT01018862 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis". The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an inv...

What is the current status of trial NCT01018862?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 489 participants. The study started on 2009-11. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01018862?

The interventions under investigation include: Placebo (DRUG), Azelastine hydrochloride nasal spray 0.15% (DRUG), Azelastine hydrochloride nasal spray 0.10% (DRUG).

Who is sponsoring clinical trial NCT01018862?

This trial is sponsored by Meda Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01018862's enrollment target sits among peer trials

489 783rd of 2000 higher than 1,217 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 NCT01018862, the US trial registry maintained by the National Library of Medicine. NCT01018862 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.