Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: SPARC1310 IIDrug: SPARC1310 IIIDrug: SPARC PlaceboDrug: SPARC1310 I
- Registration Number
- NCT01940146
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPARC1310 II SPARC1310 II - SPARC1310 III SPARC1310 III - SPARC Placebo SPARC Placebo - SPARC1310 I SPARC1310 I -
- Primary Outcome Measures
Name Time Method Change in Total Nasal Symptom Score From Baseline to Day 14. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SPARC Site 1
🇨🇦Kingston, Canada