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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00978029
First received: September 11, 2009
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy
Drug: Placebo
Biological: SCH 39641
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 42 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Proportion of Participants Reporting Oral Pruritus [ Time Frame: Up to Day 42 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 203
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo tablet sublingual, once daily
Drug: Placebo
Placebo sublingual tablet, once daily
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
Biological: SCH 39641
Allergy immunotherapy tablet (sublingual)
Other Name: MK-3641
Experimental: SCH 39641 12 Amb a 1-U
12 Amb a 1-U in an AIT, sublingual, once daily
Biological: SCH 39641
Allergy immunotherapy tablet (sublingual)
Other Name: MK-3641

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00978029     History of Changes
Other Study ID Numbers: P06081, MK-3641-004
Study First Received: September 11, 2009
Results First Received: April 25, 2014
Last Updated: November 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
immunotherapy

Additional relevant MeSH terms:
Conjunctivitis
Hypersensitivity
Conjunctival Diseases
Eye Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 27, 2014