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Trial record 9 of 12 for:    clemastine

Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00481676
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : October 21, 2011
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE June 1, 2007
First Posted Date  ICMJE June 4, 2007
Results First Submitted Date  ICMJE December 17, 2010
Results First Posted Date  ICMJE October 21, 2011
Last Update Posted Date October 21, 2011
Study Start Date  ICMJE May 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2011)
Change in the Weekly Urticaria Activity Score (UAS7) From Baseline to the End of the Study (Week 24) [ Time Frame: Baseline to end of the study (Week 24) ]
The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. Because of variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily UASs, ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change score (Week 24 score minus Baseline score) indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
Urticaria activity score (UAS) after 24 weeks of treatment in adult patients
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2011)
  • Number of Patients With Wheals, Erythemas, Pruritus, and Angioedemas at the End of the Study [ Time Frame: At the end of the study (Week 24) ]
    Patients kept a daily diary of the number of wheals and erythema and the severity of pruritus and angioedemas during the study.
  • Standardized (With Respect to Length of Time) Area Under the Curve (AUC) for the Urticaria Activity Score (UAS) From Baseline to the End of the Study (Week 24) [ Time Frame: Baseline to the end of the study (Week 24) ]
    The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total daily score (sum of the wheal and pruritus scores) ranges from 0 to 6. A higher score indicates worse disease. AUC was calculated from daily UASs where no urticaria medication was taken using the trapezoidal rule. The standardized AUC UAS was calculated as the sum of trapezoids divided by the length of time.
  • Use of Concomitant and Rescue Medications [ Time Frame: At Weeks 4, 8, 12, 16, 20, and 24 ]
    Data was collected from the patients' diaries about the number of clemastine and loratadine pills taken during the last 7 days of each month of the study.
  • Change in the Dermatology Life Quality Index (DLQI) Score From Baseline to the End of the Study (Week 24) [ Time Frame: Baseline to the end of the study (Week 24) ]
    The DLQI is a dermatology-specific quality of life (QoL) questionnaire designed for use in patients over 16 years of age. Patients are asked to respond to each of 10 questions on a 4-point Likert scale in regard to how much their skin problem has affected their life over the last week (0=not at all, 1=a little, 2=a lot, 3=very much). The overall (total) DLQI score (range=0 to 30) is calculated by summing the scores of all 10 questions. The higher the score, the more QoL is impaired. A negative change score (Week 24 score minus Baseline score) indicates improvement.
  • Change in the Skindex Score From Baseline to the End of the Study (Week 24) [ Time Frame: Baseline to the end of the study (Week 24) ]
    Skindex is a 30-item questionnaire with 3 scores (functioning, emotions,symptoms) and a composite score (average scale score) that assesses the effects of skin disease on patients' quality of life (QoL). Item responses are standardized on a scale from 0 to 100. The mean of all 61 items was calculated. A higher score indicates a lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
  • Change in Chronic Urticaria Quality of Life (CU-Q2oL) Scores From Baseline to the End of the Study (Week 24) [ Time Frame: Baseline to the end of the study (Week 24) ]
    The CU-Q2oL (German version) is a questionnaire that measures the relative burden of chronic urticaria on subjective well-being. It has 23 questions in 3 domains (symptoms, general impairment, difficulties and problems due to urticaria). Patients are asked to respond how much they are troubled by each problem on a 5-point Likert scale (1=not at all to 5=very much). Each domain and the overall (total) scores are normalized to a scale of 1 to 100. A higher score indicates lower QoL. A negative change score (Week 24 score minus Baseline score) indicates improvement.
  • Patient's Global Assessment of Their Chronic Urticaria Symptoms [ Time Frame: At Baseline and at the end of the study (Week 24) ]
    Patients made a global assessment of their chronic urticaria symptoms on a 4-point Likert scale (none, mild moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
  • Investigator's Global Assessment of the Patient's Chronic Urticaria Symptoms [ Time Frame: At Baseline and at the end of the study (Week 24) ]
    The investigator made a global assessment of the patient's chronic urticaria symptoms on a 4-point Likert scale (none, mild, moderate, severe) at Baseline and again at the end of the study. The number of patients in each category is reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • Use of rescue medication while treatment phase
  • Dermatology Life Quality Index (DLQI) at visit 2 and visit 8
  • Patient's quality of life using the Skindex at visit 2 and visit 8
  • Patient's quality of life using the chronic urticaria quality of life index
  • Investigator and Patient Global Assessment of Efficacy at visit 2 and visit 8
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria
Official Title  ICMJE A Randomized, 24 Weeks, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Adult Patients With Chronic Urticaria Who Exhibit IgE Against Thyroperoxidase
Brief Summary This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.
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 Chronic Urticaria
Intervention  ICMJE
  • Drug: Omalizumab 75-375 mg
    Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg of omalizumab upon reconstitution with 1.4 ml sterile water for injection.
    Other Name: Xolair
  • Drug: Placebo to omalizumab
    Placebo to omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 ml vial designed to deliver 150 mg placebo to omalizumab upon reconstitution with 1.4 ml sterile water for injection.
  • Drug: Loratadine
    All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
    Other Name: Lorano®
  • Drug: Clemastine
    All participants received antihistamines on demand (loratadine and clemastine), as the trial was designed to investigate the effect of omalizumab as an add-on to antihistamines in people with chronic urticaria (CU). Administration of antihistamines is the current gold standard treatment of CU. A significant proportion of people with CU is not well controlled by this standard or by using high doses of antihistamines.
    Other Name: Tavegil®
Study Arms  ICMJE
  • Experimental: Omalizumab 75-375 mg
    Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
    Interventions:
    • Drug: Omalizumab 75-375 mg
    • Drug: Loratadine
  • Placebo Comparator: Placebo to omalizumab
    Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
    Interventions:
    • Drug: Placebo to omalizumab
    • Drug: Loratadine
    • Drug: Clemastine
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: September 14, 2011)
49
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2007)
40
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Males or females from 18-70 years of age
  • Body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 IU/mL and ≤ 700 IU/mL
  • Specific serum IgE anti-TPO level ≥ 8.0 IU/mL, documented within 3 months prior to randomization or time of pre-screening
  • Diagnosis of moderate to severe chronic urticaria
  • Subject's current episode of chronic urticaria according to the European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA2LEN/EDF) guideline at the time of screening
  • Current episode of chronic urticaria has not responded to the approved marketed dose of antihistamine for 2 weeks or longer
  • Urticaria activity score (UAS) ≥ 0 at any of the 7 days of the first section of the screening period
  • UAS7 ≥ 10 at the time of randomization

Exclusion criteria:

  • Females of child-bearing potential or breast feeding
  • Present or past medical conditions that could have interfered with the study results
  • Randomized into any other omalizumab study or who had received omalizumab
  • Received investigational drugs within 30 days of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481676
Other Study ID Numbers  ICMJE CIGE025ADE05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2011

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