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Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00550550
First received: October 29, 2007
Last updated: November 10, 2014
Last verified: November 2014
Results First Received: August 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy
Interventions: Drug: Placebo
Biological: SCH 697243
Drug: Loratadine Syrup 1 mg/mL Rescue Treatment
Drug: Loratadine 10 mg Rescue Treatment
Drug: Olopatadine 0.1% Rescue Treatment
Drug: Mometasone furoate 50 mcg Rescue Treatment
Drug: Albuterol 108 mcg Rescue Treatment
Drug: Fluticasone 44 mcg Rescue Treatment
Drug: Prednisone 5 mg Rescue Treatment

  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
A total of 345 subjects were randomized at a total of 68 sites (58 sites from United States; 10 sites from Canada) to treatment assignment, and 344 subjects received at least one dose of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SCH 697243 SCH 697243 (Phleum pratense extract) administered sublingually once daily.
Placebo Matching placebo tablet administered sublingually once daily.

Participant Flow:   Overall Study
    SCH 697243     Placebo  
STARTED     176     169  
Number Treated     175     169  
COMPLETED     142     140  
NOT COMPLETED     34     29  
Adverse Event                 13                 5  
Treatment Failure                 0                 1  
Lost to Follow-up                 4                 0  
Withdrawal by Subject                 10                 8  
Protocol Violation                 5                 14  
Did Not Meet Protocol Eligibility                 1                 1  
Randomized But Not Treated                 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
SCH 697243 SCH 697243 (Phleum pratense extract) administered sublingually once daily.
Placebo Matching placebo tablet administered sublingually once daily.
Total Total of all reporting groups

Baseline Measures
    SCH 697243     Placebo     Total  
Number of Participants  
[units: participants]
  175     169     344  
Age  
[units: years]
Mean ± Standard Deviation
  12.1  ± 3.0     12.6  ± 3.0     12.3  ± 3.0  
Gender  
[units: participants]
     
Female     57     64     121  
Male     118     105     223  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)   [ Time Frame: From the Start of the GPS to the End of the GPS ]

2.  Secondary:   Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS   [ Time Frame: Start of the GPS to the End of the GPS ]

3.  Secondary:   Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS   [ Time Frame: Start of the GPS to the End of the GPS ]

4.  Secondary:   Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS   [ Time Frame: Start of the GPS to the End of the GPS ]


  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
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  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 of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00550550     History of Changes
Other Study ID Numbers: P05239, 3733251
Study First Received: October 29, 2007
Results First Received: August 7, 2012
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration