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Trial record 1 of 1 for:    NCT00291642
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A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

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ClinicalTrials.gov Identifier: NCT00291642
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : July 20, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE February 10, 2006
First Posted Date  ICMJE February 14, 2006
Results First Submitted Date  ICMJE October 10, 2017
Results First Posted Date  ICMJE July 20, 2018
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE January 1, 2006
Actual Primary Completion Date April 1, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
To compare the efficacy of levocetirizine 2.5 mg, levocetirizine 5 mg, cetirizine 5 mg and cetirizine 10 mg versus placebo as measured by the mean change from baseline of major symptoms (mean total value) related to seasonal allergic rhinitis, in ragweed
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Change From Baseline in the MSC Score Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] ]
    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) [ Time Frame: Baseline to Day 2 ]
    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I [ Time Frame: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) [ Time Frame: Baseline to Day 2 ]
    The TSC score was calculated as the sum of the following 10 individual symptom scores: runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over Period I [ Time Frame: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)] ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over Period II [ Time Frame: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)] ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
  • Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) [ Time Frame: Baseline to Day 2 ]
    Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score. The subjects had to evaluate the severity of the symptoms using a scale from "None" to "Very severe" (ranging from 0 to 5). For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
  • The secondary endpoint will evaluate:
  • - the efficacy of each active arm in reducing other SAR symptoms (calculated as mean value reduction for grouped symptoms and as absolute value reduction for each individual symptom), at different time points.
  • -the Safety .
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen
Official Title  ICMJE Double Blind, Double-dummy, Five Parallel Groups, Randomized, Exploratory Clinical Trial to Compare the Efficacy of Single Dose of Levocetirizine 2.5 mg Oral Drops (5 mg/mL), Levocetirizine 5 mg Oral Tablets, Cetirizine 5 mg Oral Drops (10 mg/mL) and Cetirizine 10 mg Oral Tablets to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Ragweed Sensitive Subjects Exposed to Ragweed Pollen in an Environmental Exposure Unit (EEU)
Brief Summary The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rhinitis
  • Allergic
  • Seasonal
Intervention  ICMJE
  • Drug: Placebo drops
    • Pharmaceutical form: Drops for oral administration
    • Route of administration: Oral use
  • Drug: Placebo tablets matching to levocetirizine
    • Pharmaceutical form: Tablets for oral administration
    • Route of administration: Oral use
  • Drug: Placebo tablets matching to cetirizine
    • Pharmaceutical form: Tablets for oral administration
    • Route of administration: Oral use
  • Drug: Levocetirizine drops
    • Pharmaceutical form: Drops for oral administration
    • Concentration: 5 mg/ml
    • Route of administration: Oral use
    Other Name: Xyzal
  • Drug: Levocetirizine tablets
    • Pharmaceutical form: Tablets for oral administration
    • Concentration: 5 mg
    • Route of administration: Oral use
    Other Name: Xyzal
  • Drug: Cetirizine drops
    • Pharmaceutical form: Drops for oral administration
    • Concentration: 10 mg/ml
    • Route of administration: Oral use
  • Drug: Cetirizine tablets
    • Pharmaceutical form: Tablets for oral administration
    • Concentration: 10 mg
    • Route of administration: Oral use
Study Arms  ICMJE
  • Placebo Comparator: Placebo (PBO)
    A single dose of placebo was administered orally on Day 1.
    Interventions:
    • Drug: Placebo drops
    • Drug: Placebo tablets matching to levocetirizine
    • Drug: Placebo tablets matching to cetirizine
  • Experimental: Levocetirizine (LCTZ) 2.5 mg
    A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
    Intervention: Drug: Levocetirizine drops
  • Experimental: Levocetirizine (LCTZ) 5 mg
    A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
    Intervention: Drug: Levocetirizine tablets
  • Experimental: Cetirizine (CTZ) 5 mg
    A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
    Intervention: Drug: Cetirizine drops
  • Experimental: Cetirizine (CTZ) 10 mg
    A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
    Intervention: Drug: Cetirizine tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)
551
Original Enrollment  ICMJE
 (submitted: February 13, 2006)
541
Actual Study Completion Date  ICMJE April 1, 2006
Actual Primary Completion Date April 1, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
  • Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
  • Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol

Exclusion Criteria:

  • Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
  • Have used forbidden concomitant medications as defined by the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00291642
Other Study ID Numbers  ICMJE A00412
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares UCB (+1 844 599 2273)
PRS Account UCB Pharma
Verification Date August 1, 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP