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NCT01614691 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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