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Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01940146
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: SPARC Placebo Drug: SPARC1310 I Drug: SPARC1310 II Drug: SPARC1310 III Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Study Start Date : October 2014
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 12, 2013    Key Record Dates
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 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