Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older (Study P06081)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00978029
First received: September 11, 2009
Last updated: May 29, 2012
Last verified: May 2012
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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 Schering-Plough:
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: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00978029 History of Changes |
| Other Study ID Numbers: | P06081 |
| Study First Received: | September 11, 2009 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
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 May 21, 2013