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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Chemotherapy-Induced Nausea and Vomiting
Intervention: Drug: Intranasal granisetron

  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
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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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

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

6.  Secondary:   Percentage of Patients With Failure   [ Time Frame: 24 hrs ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

8.  Secondary:   Time to First Emetic Episode   [ Time Frame: 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Time to First Rescue Medication   [ Time Frame: 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Time to Treatment Failure   [ Time Frame: 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Number of Emetic Episodes   [ Time Frame: 24 hours ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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

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


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


No publications provided


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
Health Authority: United States: Food and Drug Administration