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CompletedNCT00210015Updated Jan 25, 2016

A Study in Subjects With Perennial Allergic Rhinitis

A Phase 2 interventional study of INS37217 Nasal Spray in Perennial Allergic Rhinitis, sponsored by Merck Sharp & Dohme LLC. Completed. Per ClinicalTrials.gov, last updated 2016-01-25.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
630
Allocation
Randomized
01

Study summary

The purpose of this study was to determine the efficacy and safety of the study drug compared to placebo for the treatment of subjects with perennial allergic rhinitis.

02

Conditions studied

  • Perennial Allergic Rhinitis
03

In context

Rhinitis, Allergic, Perennial

186 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 8 are open to participants now.

This study's enrollment of 630 is above the median of 131 across 164 interventional studies indexed under Rhinitis, Allergic, Perennial.

Browse Rhinitis, Allergic, Perennial studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing.
  • Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies.
  • Have not started or had a change in immunotherapy regimen.

Exclusion criteria

Exclusion Criteria:

  • Have a physical obstruction in the nose.
  • Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial.
  • Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy.
  • Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms.
  • Have asthma of sufficient severity to require use of excluded medications.
  • Have taken any medications excluded as listed in the protocol.
  • Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality.
  • Are a current smoker, recent smoker or past smoker as defined in the protocol.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
630 participants

Interventions

06

What researchers measure

Primary outcomes

  1. total nasal symptom score

Secondary outcomes

  1. average total nasal symptom scores over various timepoints average individual symptom scores

  2. global assessment of perennial allergic rhinitis symptoms

  3. instantaneous assessment of symptoms

  4. change from baseline in quality of life assessments

  5. physical and anterior nasal exams

  6. laboratory tests

  7. ECG

  8. vital signs

  9. adverse events

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00210015
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
Dec 2002
Primary completion
Apr 2003
Completion
Apr 2003
Last update
Jan 25, 2016

Study contacts

Amy Schaberg, B.S.N.
study director
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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