Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

This study has been completed.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
First received: September 6, 2013
Last updated: March 10, 2016
Last verified: March 2016
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: SPARC Placebo
Drug: SPARC1310 I
Drug: SPARC1310 II
Drug: SPARC1310 III
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 SPARC1310 in Seasonal Allergic Rhinitis

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change in Total Nasal Symptom Score From Baseline to Day 14. [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
    The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.

Enrollment: 222
Study Start Date: October 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: SPARC Placebo Drug: SPARC Placebo
Experimental: SPARC1310 I Drug: SPARC1310 I
Experimental: SPARC1310 II Drug: SPARC1310 II
Experimental: SPARC1310 III Drug: SPARC1310 III


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01940146

SPARC Site 1
Kingston, Canada
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Study Director: Shravanti Bhowmik, MD Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01940146     History of Changes
Other Study ID Numbers: CLR_13_10 
Study First Received: September 6, 2013
Results First Received: November 19, 2015
Last Updated: March 10, 2016
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 30, 2016