A Study in Subjects With Perennial Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00210015
First received: September 13, 2005
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: INS37217 Nasal Spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Parallel-Group, Double-Blind, Efficacy and Safety Study of INS37217 Nasal Spray Versus Placebo in Subjects With Perennial Allergic Rhinitis

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • total nasal symptom score

Secondary Outcome Measures:
  • average total nasal symptom scores over various timepoints average individual symptom scores
  • global assessment of perennial allergic rhinitis symptoms
  • instantaneous assessment of symptoms
  • change from baseline in quality of life assessments
  • physical and anterior nasal exams
  • laboratory tests
  • ECG
  • vital signs
  • adverse events

Estimated Enrollment: 630
Study Start Date: December 2002
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210015

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, B.S.N.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210015     History of Changes
Other Study ID Numbers: 07-105
Study First Received: September 13, 2005
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014