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NCT01368445 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies

A Phase 3 study, sponsored by Meda Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
617
Enrollment target

NCT01368445: Completed Phase 3 study, sponsored by Meda Pharmaceuticals.

NCT01368445 is a Phase 3 study that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 617 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01368445, a Phase 3 study, has completed, sponsored by Meda Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
617 participants
Enrollment target

Study Summary

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

Interventions

  • DRUG azelastine hydrochloride 0.15% Nasal Spray
  • DRUG azelastine hydrochloride 0.15% and Placebo
  • DRUG Azelastine 0.1%, Nasal Spray

Trial Details

FieldValue
Enrollment Target 617 participants
Start Date 2006-08
Est. Completion 2008-04
Phase Phase 3
Meda Pharmaceuticals

19 total trials

What the finished NCT01368445 record still lists

NCT01368445 is an interventional study that assigns participants to a tested intervention. The registered 617 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 (20% lower).

The record links to 0 conditions, and to 3 interventions - of which azelastine hydrochloride 0.15% Nasal Spray is the first listed.

NCT01368445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01368445 about?

NCT01368445 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies". The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

What is the current status of trial NCT01368445?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2006-08. Estimated completion is 2008-04.

What interventions are being tested in trial NCT01368445?

The interventions under investigation include: azelastine hydrochloride 0.15% Nasal Spray (DRUG), azelastine hydrochloride 0.15% and Placebo (DRUG), Azelastine 0.1%, Nasal Spray (DRUG).

Who is sponsoring clinical trial NCT01368445?

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 NCT01368445's enrollment target sits among peer trials

617 592nd of 2000 higher than 1,408 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 NCT01368445, the US trial registry maintained by the National Library of Medicine. NCT01368445 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.