7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00115089
First received: June 20, 2005
Last updated: November 9, 2005
Last verified: November 2005
  Purpose

This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone dipropionate, an established FDA approved steroid treatment), and an inactive placebo. The study hypothesis is that R926112 will be superior to placebo at the end of a week of testing and evaluation. The study does not have the power to determine how R926112 compares to Beconase.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: R926112
Drug: Beclomethasone dipropionate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Rigel Pharmaceuticals:

Primary Outcome Measures:
  • Change in total nasal symptom score from baseline over time

Secondary Outcome Measures:
  • Change in individual symptoms
  • Global therapeutic response
  • Quality of life score

Estimated Enrollment: 375
Study Start Date: July 2005
Estimated Study Completion Date: September 2005
Detailed Description:

Seven hundred fifty patients with histories of seasonal allergies will be screened in late summer and early fall at 25 sites across the U.S. Approximately 375 patients, based on severity of symptoms will be randomized among the treatments (150 to R926112, 150 to placebo, 75 to Beconase). During, and for about 2-3 weeks prior to the study, patients will have to abstain from other anti-allergy medications. Patients will fill out diary cards two times per day to record their symptoms. The entire study should take between 2-4 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must sign a written informed consent form and assent (if applicable) for study participation.
  • Males and females, 12 years of age or older
  • Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the previous 2 years.
  • Subjects must be skin test positive to a relevant fall aeroallergen within the past 12 months with at least a moderate reaction as defined by at least a 5 mm wheal.
  • Nasal exam to exclude significant swelling, bleeding, crusting, or polyps
  • Subjects receiving immunotherapy must be on a stable maintenance regimen for at least 30 days before screening. Adjustments to the regimen following a brief period of missed injections or the normal reduction in dose due to a vaccine refill does not preclude participation.
  • Female subjects of childbearing potential must have negative urine tests for pregnancy at Visits 1 and 2.
  • Female subjects of childbearing potential who are sexually active will be expected to use a medically recognized birth control method throughout the study: systemic contraceptive (oral, implant, injection, patch), diaphragm with intravaginal spermicide, cervical cap, vaginal ring, intrauterine device, or condom with spermicide. Females who are not sexually active will be admitted by the discretion of the Investigator. Acceptable birth control will be documented in the subject’s case report form.
  • Subjects must be willing to adhere to dosing schedules, study visits, and study requirements.

Exclusion Criteria:

  • Clinically significant medical conditions (such as hepatic, neurological, hematological, renal, cardiac, gastrointestinal, endocrine, or other major systemic disease), which in the judgment of the Investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult.
  • Clinically relevant abnormalities in laboratory results or electrocardiogram (ECG) as determined by the investigator
  • Asthma that requires treatment other than with inhaled, short acting beta agonist alone.
  • Female subjects who are pregnant, trying to become pregnant, or nursing.
  • Nasal structural abnormalities, including large nasal polyps or marked septal deviation that significantly interfere with nasal airflow or nasal surgery within the past year.
  • Upper respiratory infection within 3 weeks before the date of Randomization/Visit 2.
  • Treatment with any investigational drug in the last 30 days before the date of Randomization/Visit 2.
  • History of drug or alcohol abuse that according to the Investigator could interfere with the study.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Subjects unlikely to comply with study procedures, unable to return for study visits, or unlikely to complete the study, or expecting or planning to travel outside the area of the prevalent aeroallergen during the study period.
  • History of hypersensitivity to steroids or to the excipients.
  • Use of tricyclic antidepressants within the past 30 days prior to date of Randomization/Visit 2.
  • Ocular herpes simplex or cataracts present at the time of Screening Visit.
  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: NCT00115089

Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Elliott Grossbard, M.D. Rigel Pharmaceuticals
Principal Investigator: Eli Meltzer, M.D. Allergy and Asthma Medical Group and Research Center, San Diego
Principal Investigator: Harold Nelson, M.D. National Jewish Medical Research Center, Denver
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00115089     History of Changes
Other Study ID Numbers: C-926112-005A
Study First Received: June 20, 2005
Last Updated: November 9, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Rigel Pharmaceuticals:
Allergic Rhinitis
Nasal Spray
Seasonal Allergic Rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014