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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:
ClinicalTrials.gov Identifier:
NCT00978029
First Posted: September 16, 2009
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
Results First Submitted: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy
Interventions: Drug: Placebo
Biological: SCH 39641

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to non-compliance with Good Clinical Practice (GCP) 7 randomized participants who completed treatment were excluded from all subsequent analysis.

Reporting Groups
  Description
Placebo Matching placebo tablet sublingual, once daily
SCH 39641 6 Amb a 1-U 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
SCH 39641 12 Amb a 1-U 12 Amb a 1-U in an AIT, sublingual, once daily

Participant Flow:   Overall Study
    Placebo   SCH 39641 6 Amb a 1-U   SCH 39641 12 Amb a 1-U
STARTED   65   66   65 
COMPLETED   64   63   59 
NOT COMPLETED   1   3   6 
Adverse Event                1                2                5 
Withdrawal by Subject                0                0                1 
Protocol Violation                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching placebo tablet sublingual, once daily
SCH 39641 6 Amb a 1-U 6 Amb a 1-U in an AIT, sublingual, once daily
SCH 39641 12 Amb a 1-U 12 Amb a 1-U in an AIT, sublingual, once daily
Total Total of all reporting groups

Baseline Measures
   Placebo   SCH 39641 6 Amb a 1-U   SCH 39641 12 Amb a 1-U   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   66   65   196 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.4  (4.7)   56.4  (5.4)   56.2  (5.7)   56.3  (5.3) 
Gender 
[Units: Participants]
Count of Participants
       
Female      38  58.5%      43  65.2%      40  61.5%      121  61.7% 
Male      27  41.5%      23  34.8%      25  38.5%      75  38.3% 


  Outcome Measures
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1.  Primary:   The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs)   [ Time Frame: Up to Day 42 ]

2.  Secondary:   Proportion of Participants Reporting Oral Pruritus   [ Time Frame: Up to Day 42 ]

3.  Secondary:   Proportion of Participants Reporting Ear Pruritus   [ Time Frame: Up to Day 42 ]

4.  Secondary:   Proportion of Participants Reporting Throat Irritation   [ Time Frame: Up to Day 42 ]

5.  Secondary:   Proportion of Participants Reporting Mouth Oedema   [ Time Frame: Up to Day 42 ]

6.  Secondary:   Proportion of Participants Who Discontinued Due to Adverse Events.   [ Time Frame: Up to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00978029     History of Changes
Other Study ID Numbers: P06081
MK-3641-004 ( Other Identifier: Merck )
First Submitted: September 11, 2009
First Posted: September 16, 2009
Results First Submitted: April 25, 2014
Results First Posted: May 23, 2014
Last Update Posted: March 3, 2017