A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

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Organon

Status and phase

Completed
Phase 3

Conditions

Perennial Allergic Rhinitis

Treatments

Drug: Placebo
Drug: Desloratadine 5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01918033
132244 (Registry Identifier)
4117-200

Details and patient eligibility

About

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.

Enrollment

608 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with perennial allergic rhinitis
  • Outpatient.

Exclusion criteria

  • Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)
  • Coexisting infections or systemic mycosis for which there are no effective antibiotics
  • Asthma complication under treatment
  • Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed
  • Vasomotor rhinitis or eosinophilic rhinitis
  • Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug
  • History of hypersensitivity to antihistamines or study drug
  • Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months
  • Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent
  • Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
  • History of malignancy or clinically important hematological disorder
  • History of severe drug allergy (e.g., anaphylactoid reaction).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

608 participants in 3 patient groups, including a placebo group

Desloratadine 5 mg
Experimental group
Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Treatment:
Drug: Desloratadine 5 mg
Drug: Placebo
Desloratadine 10 mg
Experimental group
Description:
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Treatment:
Drug: Desloratadine 5 mg
Placebo
Placebo Comparator group
Description:
Participants receive two placebo tablets orally once daily for up to 2 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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