Efficacy and Safety of S0597 in Seasonal Allergic Rhinitis

This study is not yet open for participant recruitment.
Verified September 2013 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01940146
First received: September 6, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

The study will assess the efficacy and safety of intranasal S0597 when compared to placebo and active control in an environmental exposure unit model following 2 weeks of treatment


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: S0597 low dose
Drug: S0597 mid dose
Drug: S0597 high dose
Drug: Reference
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intranasal S0597 in an Environmental Exposure Unit Model of Seasonal Allergic Rhinitis: A Phase 2, Single-center, Randomized, Double-blind, Placebo and Active-controlled Parallel Group Study

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Total nasal symptom score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Change in Total nasal symptom score from baseline to end of treatment at 2 weeks


Estimated Enrollment: 275
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo
Experimental: S0597 low dose Drug: S0597 low dose
S0597 low dose
Experimental: S0597 mid dose Drug: S0597 mid dose
S0597 mid dose
Experimental: S0597 high dose Drug: S0597 high dose
S0597 high dose
Active Comparator: Comparator Drug: Reference
reference comparator

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
  • Participants able to understand and willing to sign the informed consent form

Exclusion Criteria:

  • Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
  • Pregnant or nursing women
  • Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
  • Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940146

Contacts
Contact: Anne K Elllis, MD 613-548-2336

Locations
Canada
Kingston General Hospital Not yet recruiting
Kingston, Canada
Contact: Anne K Ellis, MD    613-548-2336      
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Principal Investigator: Anne K Ellis, MD Kingston General Hospital
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01940146     History of Changes
Other Study ID Numbers: SPARC Ltd CLR_13_10
Study First Received: September 6, 2013
Last Updated: September 6, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014