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

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: September 16, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the safety a ragweed allergy immunotherapy tablet 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
Biological: 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 subjects reporting treatment-emergent adverse events [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects reporting local adverse events including oral pruritus, ear pruritus, throat irritation, and mouth edema [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Frequency of discontinuations due to adverse events. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 204
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
Biological: Placebo
Placebo sublingual tablet, once daily
Experimental: SCH 39641 6 Developmental Units (DU)
Ragweed Allergy Immunotherapy Tablet (Ambrosia artemisiifolia) 6 DU
Biological: SCH 39641
Allergy immunotherapy tablet (sublingual)
Experimental: SCH 39641 12 DU
Ragweed Allergy Immunotherapy Tablet (Ambrosia artemisiifolia) 12 DU
Biological: SCH 39641
Allergy immunotherapy tablet (sublingual)

  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/sponsor.

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00978029     History of Changes
Other Study ID Numbers: P06081
Study First Received: September 11, 2009
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Rhinitis
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014