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Safety and Efficacy of SPARC1203 in Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614691
First Posted: June 8, 2012
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
  Purpose
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: Quadruple (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
Active
Experimental: SPARC1203 mid dose Drug: SPARC1203
Active
Experimental: SPARC1203 high dose Drug: SPARC1203
Active
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

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
Criteria

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


Locations
Germany
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 Submitted: June 6, 2012
First Posted: June 8, 2012
Last Update Posted: March 14, 2016
Last Verified: March 2016

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