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Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01940146
First received: September 6, 2013
Last updated: March 10, 2016
Last verified: March 2016
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    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
Placebo
Experimental: SPARC1310 I Drug: SPARC1310 I
SPARC1310 I
Experimental: SPARC1310 II Drug: SPARC1310 II
SPARC1310 II
Experimental: SPARC1310 III Drug: SPARC1310 III
SPARC1310 III

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

ClinicalTrials.gov processed this record on April 21, 2017