Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: SPARC1310 II; Drug: SPARC1310 III; Drug: SPARC Placebo; Drug: 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

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-12
• Study Start: 2014-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-11-19
• Results First Submitted QC: 2016-03-10
• Results First Posted: 2016-04-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

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.

Trial Locations

Locations (1)

SPARC Site 1; 🇨🇦 Kingston, Canada