Safety and Efficacy of SPARC1203 in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT01614691
First received: June 6, 2012
Last updated: March 10, 2016
Last verified: March 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 6, 2012
Last Updated: March 10, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 25, 2016