Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: SPARC1310 I; Drug: SPARC1310 II; Drug: SPARC Placebo; Drug: SPARC1310 III

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940146

CLR_13_10

Details and patient eligibility

About

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

Enrollment: 222 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 4 patient groups, including a placebo group

SPARC Placebo

Placebo Comparator group

Treatment:

Drug: SPARC Placebo

SPARC1310 I

Experimental group

Treatment:

Drug: SPARC1310 I

SPARC1310 II

Experimental group

Treatment:

Drug: SPARC1310 II

SPARC1310 III

Experimental group

Treatment:

Drug: SPARC1310 III