Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614691
• Other study ID #: CLR_12_03
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2019
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• SPARC1203
Active
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	SPARC Site 1	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Nasal Symptom Score (TNSS)		Baseline and 2 weeks