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NCT01940146 Clinical Trial

Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01940146
Other study ID # CLR_13_10
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date December 2014

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

The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SPARC Placebo
Placebo
• SPARC1310 I
SPARC1310 I
• SPARC1310 II
SPARC1310 II
• SPARC1310 III
SPARC1310 III

Locations
Country Name City State
Canada SPARC Site 1 Kingston

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Total Nasal Symptom Score From 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. Baseline to Day 14
See also
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