Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SPARC Placebo

Group Type PLACEBO_COMPARATOR

SPARC Placebo

Intervention Type DRUG

Placebo

SPARC1310 I

Group Type EXPERIMENTAL

SPARC1310 I

Intervention Type DRUG

SPARC1310 I

SPARC1310 II

Group Type EXPERIMENTAL

SPARC1310 II

Intervention Type DRUG

SPARC1310 II

SPARC1310 III

Group Type EXPERIMENTAL

SPARC1310 III

Intervention Type DRUG

SPARC1310 III

Interventions

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SPARC Placebo

Placebo

Intervention Type DRUG

SPARC1310 I

Intervention Type DRUG

SPARC1310 II

Intervention Type DRUG

SPARC1310 III

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No