Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01614691

Enrollment

159

Registered

2012-06-08

Start date

2012-06-30

Completion date

2013-03-31

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief summary

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

Interventions

DRUGSPARC1203

Active

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Total Nasal Symptom Score (TNSS)	Baseline and 2 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026