Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SPARC1203 low dose

Group Type EXPERIMENTAL

SPARC1203

Intervention Type DRUG

Active

SPARC1203 mid dose

Group Type EXPERIMENTAL

SPARC1203

Intervention Type DRUG

Active

SPARC1203 high dose

Group Type EXPERIMENTAL

SPARC1203

Intervention Type DRUG

Active

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SPARC1203

Active

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No