Safety and Efficacy of SPARC1203 in Allergic Rhinitis

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

Completed

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SPARC Site 1

Hanover, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1203

Drug

Active

Placebo

Drug

Placebo

Primary outcomes

Change in Total Nasal Symptom Score (TNSS)

Time frame: Baseline and 2 weeks

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Jun 8, 2012
Registry last updated: May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed