Efficacy and Safety of S0597 in Seasonal Allergic Rhinitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
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: 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 July 29, 2014