Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Phase 2CompletedNCT01940146

Sun Pharma Advanced Research Company Limited222 enrolled

Overview

The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

222

Conditions

Seasonal Allergic Rhinitis

Interventions

SPARC PlaceboDRUG

Placebo

SPARC1310 IDRUG

SPARC1310 I

SPARC1310 IIDRUG

SPARC1310 II

SPARC1310 III

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

SPARC Site 1

Kingston, Canada

Outcomes

Primary Outcomes

Change in Total Nasal Symptom Score From 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.

Time frame: Baseline to Day 14

Data from ClinicalTrials.gov

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