A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT01469182

First received: October 21, 2011

Last updated: April 24, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 21, 2011
Last Updated Date	April 24, 2012
Start Date ^ICMJE	November 2011
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 9, 2011)	Number of Participants who Report Treatment-emergent Adverse Events (AEs) [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01469182 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 9, 2011)	Number of Participants Reporting Local AEs (oral pruritus, ear pruritus, throat irritation, mouth edema, eye pruritus, nasal passage irritation, and skin pruritus) [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ] Number of Discontinuations due to Treatment-emergent AEs [ Time Frame: Up to Day 35 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)
Official Title ^ICMJE	A 28-Day Study Evaluating the Safety of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet (SCH 39641/MK-3641) Treatment in Ragweed Allergic Adults (Phase 3, Protocol No.P05751)
Brief Summary	This study will assess the safety profile of the short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Allergy
Intervention ^ICMJE	Drug: SCH 39641 (MK-3641) Rapidly dissolving tablet sublingually once daily Other Name: Short ragweed (Ambrosia artemisiifolia) pollen allergen extract Drug: Placebo for SCH 39641 (MK-3641) Rapidly dissolving tablet sublingually once daily
Study Arm (s)	Experimental: SCH 39641 (MK-3641) Intervention: Drug: SCH 39641 (MK-3641) Placebo Comparator: Placebo Intervention: Drug: Placebo for SCH 39641 (MK-3641)
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
Enrollment ^ICMJE	914
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma Must have a positive skin prick test response to Ambrosia artemisiifolia Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value 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 Females of child-bearing potential must agree to use medically accepted methods of contraception Exclusion Criteria: Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months Received an immunosuppressive treatment within 3 months History of anaphylaxis with cardio-respiratory symptoms. History of chronic urticaria or angioedema Current severe atopic dermatitis Female subject who is breastfeeding, pregnant, or intending to become pregnant Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine Unable to or will not comply with the use of self-injectable epinephrine Participating in any other clinical trial
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01469182
Other Study ID Numbers ^ICMJE	P05751
Has Data Monitoring Committee	No
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top