Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis

• Status: Unknown status
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Strategic Biosciences
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• Willing to participate as indicated by providing written informed consent

• 12 years of age or older, of any gender and any race

• Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years

• A history of allergic rhinitis, for at least 2 years

• Have undergone washout of all medications that could have an influence on the study

• Willing and able to make required study visits

• Able to follow instructions and record diary symptoms.

• Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination

• Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2

• Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2.

Exclusion Criteria:

• any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps

• any other anatomic nasal deformity that could interfere with their participation in the study

• asthma, with the exception of mild intermittent asthma

• congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)

• use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days

• be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study

• Be using dermal potent or super-potent topical corticosteroids

• any systemic disorder that could interfere with the evaluation of the study medication

• hypersensitivity to the study drugs or any component thereof

• history of drug or alcohol abuse that would interfere with participation in the study

• history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study

• upper or lower respiratory infection within 14 days of Vist 2

• acute sinusitis within 30 days of Visit 2

• any history or evidence of nasolacrimal drainage system malfunction

• Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week.

• participation in any other investigational study within 30 days before entry into this study or concomitantly with this study

• chronic or intermittent use of any prescription or over-the-counter (OTC) nasal spray during the study period