Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03181)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00794495
First received: November 19, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis
Drug: Desloratadine 5 mg (Clarinex)
Drug: Cetirizine (Zyrtec)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Preference Evaluation of Clarinex Tablets vs. Zyrtec Tablets in Subjects With Symptomatic Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The primary efficacy measure was the preference rates calculated from subject comparative evaluation. [ Time Frame: 1 day after the last treatment period (Visit 5) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject Non-Comparative Evaluation and subject Response to Therapy [ Time Frame: 1 day after the end of each 7-day treatment period (Visit 3 and Visit 5) ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: December 2002
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clarinex followed by Zyrtec
Clarinex 5 mg by mouth daily for 7 days followed by Zyrtec 10 mg by mouth daily for 7 days, with 5-28 days washout between treatments.
Drug: Desloratadine 5 mg (Clarinex)
Clarinex 5 mg daily x 7 days
Other Name: Clarinex, SCH 34117
Drug: Cetirizine (Zyrtec)
Zyrtec 10 mg daily x 7 days
Other Name: Zyrtec®
Experimental: Zyrtec followed by Clarinex
Zyrtec 10 mg by mouth daily for 7 days followed by Clarinex 5 mg by mouth daily for 7 days, with 5-28 days washout between treatments.
Drug: Desloratadine 5 mg (Clarinex)
Clarinex 5 mg daily x 7 days
Other Name: Clarinex, SCH 34117
Drug: Cetirizine (Zyrtec)
Zyrtec 10 mg daily x 7 days
Other Name: Zyrtec®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
  • currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
  • had not taken Zyrtec® or Clarinex® within the previous year;
  • were 18 years of age or older;
  • had negative urine test (hCG) for females of childbearing potential;
  • for women of childbearing potential, agreed to use a medically accepted method of birth control;
  • were free of any clinically significant disease (other than AR) that would interfere with study evaluations.

Exclusion Criteria:

  • were pregnant or nursing;
  • had allergic or idiosyncratic reaction to antihistamines;
  • had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
  • had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
  • in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
  • had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
  • had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
  • were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
  • had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
  • had a history of non-compliance with medications or treatment protocols;
  • had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
  • had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
  • had liver or renal impairment.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00794495     History of Changes
Other Study ID Numbers: P03181
Study First Received: November 19, 2008
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Desloratadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on October 19, 2014