Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: SPARC1203; Drug: Placebo

• Registration Number: NCT01614691
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Primary Completion: 2012-11
• Study Completion: 2013-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Male and female patients aged 18 to 65 years (both inclusive) with history of seasonal allergic rhinitis and positive skin prick test

Exclusion Criteria

• History or presence of perennial allergic rhinitis
• Upper or lower respiratory tract infection 2 weeks before Visit 2
• Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone
• Immunizations or vaccinations within 4 weeks prior to Visit 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC1203 low dose	SPARC1203	-
SPARC1203 mid dose	SPARC1203	-
Placebo	Placebo	-
SPARC1203 high dose	SPARC1203	-

Primary Outcome Measures

Name	Time	Method
Change in Total Nasal Symptom Score (TNSS)	Baseline and 2 weeks

Trial Locations

Locations (1)

SPARC Site 1; 🇩🇪 Hannover, Germany