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Safety and Efficacy of SPARC1203 in Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01614691
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : March 14, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess safety and efficacy of SPARC1203 delivered via nasal spray in patients with allergic rhinitis

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: SPARC1203 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2012
Primary Completion Date : November 2012
Study Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: SPARC1203 low dose Drug: SPARC1203
Experimental: SPARC1203 mid dose Drug: SPARC1203
Experimental: SPARC1203 high dose Drug: SPARC1203
Placebo Comparator: Placebo Drug: Placebo

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614691

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01614691     History of Changes
Other Study ID Numbers: CLR_12_03
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases