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Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)

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ClinicalTrials.gov Identifier: NCT00978029
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : May 23, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

September 11, 2009
September 16, 2009
April 25, 2014
May 23, 2014
March 3, 2017
November 2009
February 2010   (Final data collection date for primary outcome measure)
The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 42 ]
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.
The proportion of subjects reporting treatment-emergent adverse events [ Time Frame: 28 days ]
Complete list of historical versions of study NCT00978029 on ClinicalTrials.gov Archive Site
  • Proportion of Participants Reporting Oral Pruritus [ Time Frame: Up to Day 42 ]
    Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported.
  • Proportion of Participants Reporting Ear Pruritus [ Time Frame: Up to Day 42 ]
    Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported.
  • Proportion of Participants Reporting Throat Irritation [ Time Frame: Up to Day 42 ]
    Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported.
  • Proportion of Participants Reporting Mouth Oedema [ Time Frame: Up to Day 42 ]
    Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported.
  • Proportion of Participants Who Discontinued Due to Adverse Events. [ Time Frame: Up to Day 28 ]
    Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Proportion of subjects reporting local adverse events including oral pruritus, ear pruritus, throat irritation, and mouth edema [ Time Frame: 28 days ]
  • Frequency of discontinuations due to adverse events. [ Time Frame: 28 days ]
Not Provided
Not Provided
 
Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)
A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet (SCH 39641) in Adult Subjects 50 Years of Age and Older With Ragweed-Induced Rhinoconjunctivitis (Protocol No. P06081)
The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Rhinoconjunctivitis
  • Rhinitis
  • Conjunctivitis
  • Allergy
  • Drug: Placebo
    Placebo sublingual tablet, once daily
  • Biological: SCH 39641
    Allergy immunotherapy tablet (sublingual)
    Other Name: MK-3641
  • Placebo Comparator: Placebo
    Matching placebo tablet sublingual, once daily
    Intervention: Drug: Placebo
  • Experimental: SCH 39641 6 Amb a 1-U
    6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily
    Intervention: Biological: SCH 39641
  • Experimental: SCH 39641 12 Amb a 1-U
    12 Amb a 1-U in an AIT, sublingual, once daily
    Intervention: Biological: SCH 39641
Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hébert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
200
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be 50 years of age or older, of either sex, and of any race/ethnicity.
  • Subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma.
  • Subject must have a positive skin prick test response to Ambrosia artemisiifolia at the Screening Visit
  • Subject must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at the Screening Visit and at Randomization.
  • A subject's clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

Exclusion Criteria:

  • Subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period.
  • Subject requiring anti-allergy medications during the time period from randomization to study completion.
  • Subject who has received an immunosuppressive treatment within 3 months prior to the Screening Visit (except steroids for allergic and asthma symptoms).
  • Subject with a history of anaphylaxis with cardiorespiratory symptoms.
  • Subject with a history of chronic urticaria or angioedema.
  • Subject with current severe atopic dermatitis.
  • Female subject who is breastfeeding, pregnant, or intending to become pregnant.
  • Subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine.
  • Subject with a history of self-injectable epinephrine use.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00978029
P06081
MK-3641-004 ( Other Identifier: Merck )
No
Not Provided
Not Provided
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Not Provided
ALK-Abelló A/S
January 2017

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