Safety and Efficacy of SPARC1203 in Allergic Rhinitis

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo; Drug: SPARC1203

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614691

CLR_12_03

Details and patient eligibility

About

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

Enrollment: 159 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

159 participants in 4 patient groups, including a placebo group

SPARC1203 low dose

Experimental group

Treatment:

Drug: SPARC1203

SPARC1203 mid dose

Experimental group

Treatment:

Drug: SPARC1203

SPARC1203 high dose

Experimental group

Treatment:

Drug: SPARC1203

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo