Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00562159
First received: November 20, 2007
Last updated: November 11, 2013
Last verified: November 2013
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, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Rhinoconjunctivitis
Rhinitis
Conjunctivitis
Allergy
Interventions: Drug: Placebo
Biological: SCH 697243
Drug: Loratadine 10 mg Rescue Treatment
Drug: Olopatadine 0.1% Rescue Treatment
Drug: Mometasone 50 mcg Rescue Treatment
Drug: Prednisone 5 mg Rescue Treatment
Drug: Albuterol sulfate 108 mcg
Drug: Fluticasone propionate 44 mcg
Drug: Prednisone 5 mg

  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 439 participants were randomized at a total of 62 sites (53 sites from US; 9 sites from Canada) to treatment assignment, and 438 participants received at least one dose of study medication: 213 participants received SCH 697243 and 225 received placebo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty five participants from the observation year did not continue on to the treatment year; 14 participants were not eligible and 21 participants were screen failures.

Reporting Groups
  Description
SCH 697243 Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
Placebo Rapidly dissolving matching placebo tablets administered sublingually once daily.

Participant Flow:   Overall Study
    SCH 697243     Placebo  
STARTED     213     225  
COMPLETED     175     192  
NOT COMPLETED     38     33  
Adverse Event                 11                 8  
Lost to Follow-up                 5                 4  
Withdrawal by Subject                 9                 8  
Protocol Violation                 12                 12  
Did not meet protocol eligibility                 1                 1  



  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 Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
Placebo Rapidly dissolving matching placebo tablets administered sublingually once daily.
Total Total of all reporting groups

Baseline Measures
    SCH 697243     Placebo     Total  
Number of Participants  
[units: participants]
  213     225     438  
Age  
[units: years]
Mean ± Standard Deviation
  35.9  ± 11.1     35.9  ± 9.8     35.9  ± 10.5  
Gender  
[units: participants]
     
Female     109     112     221  
Male     104     113     217  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00562159     History of Changes
Other Study ID Numbers: P05238, 3727105
Study First Received: November 20, 2007
Results First Received: August 7, 2012
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration