Safety and Efficacy of S0597 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: August 5, 2013
Last verified: August 2013
  Purpose

This study will assess safety and efficacy of S0597 delivered via nasal spray in patients with allergic rhinitis


Condition Intervention Phase
Allergic Rhinitis
Drug: S0597
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
Official Title: Efficacy and Safety of Intranasal S0597 in Environmental Exposure Chamber Model of Seasonal Allergic Rhinitis: A Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study

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: S0597 low dose Drug: S0597
Active
Experimental: S0597 mid dose Drug: S0597
Active
Experimental: S0597 high dose Drug: S0597
Active
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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
Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
Hannover, Germany, 30625
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Investigators
Principal Investigator: Philipp Badorrek, MD Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM)
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT01614691     History of Changes
Other Study ID Numbers: SPARC_Ltd._CLR_12_03
Study First Received: June 6, 2012
Last Updated: August 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 16, 2014