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Safety and Efficacy of SPARC1203 in Allergic Rhinitis

This study has been completed.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: June 6, 2012
Last updated: March 10, 2016
Last verified: March 2016
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis

Condition Intervention Phase
Allergic Rhinitis
Drug: SPARC1203
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Change in Total Nasal Symptom Score (TNSS) [ Time Frame: Baseline and 2 weeks ]

Enrollment: 159
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1203 low dose Drug: SPARC1203
Experimental: SPARC1203 mid dose Drug: SPARC1203
Experimental: SPARC1203 high dose Drug: SPARC1203
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01614691

SPARC Site 1
Hannover, Germany
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01614691     History of Changes
Other Study ID Numbers: CLR_12_03
Study First Received: June 6, 2012
Last Updated: March 10, 2016

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 25, 2017