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Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by:
Shin Nippon Biomedical Laboratories, Ltd.
ClinicalTrials.gov Identifier:
NCT00787566
First received: November 5, 2008
Last updated: July 5, 2011
Last verified: July 2011
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Chemotherapy-Induced Nausea and Vomiting
Intervention: Drug: Intranasal granisetron

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
0.5 mg of TRG (Intranasal Granisetron) 0.5 mg dose, intranasal powder, single spray, administered once
1.0 mg of TRG (Intranasal Granisetron) 1.0 mg dose, intranasal powder, single spray, administered once
2.0 mg of TRG (Intranasal Granisetron) 2.0 mg dose, intranasal powder, single spray, administered once

Participant Flow:   Overall Study
    0.5 mg of TRG (Intranasal Granisetron)   1.0 mg of TRG (Intranasal Granisetron)   2.0 mg of TRG (Intranasal Granisetron)
STARTED   21   25   22 
COMPLETED   21   24 [1]   22 
NOT COMPLETED   0   1   0 
AE related to chemotherapy                0                1                0 
[1] 1 patient withdrew from the study due to an AE related to chemotherapy agent administration.



  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
0.5 mg of TRG (Intranasal Granisetron) 0.5 mg dose, intranasal powder, single spray, administered once
1.0 mg of TRG (Intranasal Granisetron) 1.0 mg dose, intranasal powder, single spray, administered once
2.0 mg of TRG (Intranasal Granisetron) 2.0 mg dose, intranasal powder, single spray, administered once
Total Total of all reporting groups

Baseline Measures
   0.5 mg of TRG (Intranasal Granisetron)   1.0 mg of TRG (Intranasal Granisetron)   2.0 mg of TRG (Intranasal Granisetron)   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   25   22   68 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   14   17   14   45 
>=65 years   7   8   8   23 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.4  (15.9)   60.0  (10.2)   61.0  (12.0)   58.9  (12.8) 
Gender 
[Units: Participants]
       
Female   19   17   17   53 
Male   2   8   5   15 
Region of Enrollment 
[Units: Participants]
       
United States   21   25   22   68 


  Outcome Measures

1.  Primary:   Percentage of Patients With Complete Control   [ Time Frame: 24 hours ]

2.  Secondary:   Percentage of Patients With Complete Response   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Percentage of Patients With Total Response   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Percentage of Patients With Major Control of Emesis   [ Time Frame: 24 hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Percentage of Patients With Minor Control of Emesis   [ Time Frame: 24 hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Percentage of Patients With Failure   [ Time Frame: 24 hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Percentage of Patients Using Rescue Medications   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Time to First Emetic Episode   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Time to First Rescue Medication   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Time to Treatment Failure   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Number of Emetic Episodes   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Severity of Nausea Measured by a 4 Categorical Scale   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Patient Global Satisfaction With Antiemetic Therapy Measured by a VAS   [ Time Frame: 24 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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: Vanaja V. Ragavan, M.D.
Organization: Aviana Consulting, LLC
phone: 610-795-7403
e-mail: vvragavan@comcast.net



Responsible Party: Vanaja Ragavan, MD, Aviana Consulting, LLC
ClinicalTrials.gov Identifier: NCT00787566     History of Changes
Other Study ID Numbers: TRG-002
Study First Received: November 5, 2008
Results First Received: May 24, 2011
Last Updated: July 5, 2011