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

Resource links provided by NLM:


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
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, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014