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Regimen for the Treatment of Cachexia in Subjects With NSCLC (VT-122)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527319
First Posted: September 10, 2007
Last Update Posted: January 30, 2013
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):
Vicus Therapeutics
Results First Submitted: November 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Cachexia
Interventions: Drug: VT-122 low dose
Drug: VT-122 high dose

  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
First patient visit: March 23, 2007 Last patient visit: December 10, 2008

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
Group A, Control Group Supportive care only
Group B, Low Dose VT-122 VT-122 low dose Supportive care
Group C, High Dose VT-122 VT-122 high dose Supportive care

Participant Flow:   Overall Study
    Group A, Control Group   Group B, Low Dose VT-122   Group C, High Dose VT-122
STARTED   12   12   13 
COMPLETED   6   8   7 
NOT COMPLETED   6   4   6 
Withdrawal by Subject                5                0                1 
Lost to Follow-up                1                0                0 
Death                0                3                1 
Intercurrent Medical Illness                0                1                3 
Adverse Event                0                0                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
Group A, Control Group Supportive care only
Group B, Low Dose VT-122 VT-122 (dose of etodolac: 400 mg/day) + supportive care
Group C, High Dose VT-122 VT-122 (dose of etodolac: 800 mg/day) + supportive care
Total Total of all reporting groups

Baseline Measures
   Group A, Control Group   Group B, Low Dose VT-122   Group C, High Dose VT-122   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   13   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.1  (12.0)   55.1  (7.6)   57.6  (10.4)   55.7  (10.1) 
Gender 
[Units: Participants]
       
Female   3   6   3   12 
Male   9   6   10   25 
Region of Enrollment 
[Units: Participants]
       
India   12   12   13   37 


  Outcome Measures
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1.  Primary:   Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass   [ Time Frame: 4 weeks ]

2.  Primary:   Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength   [ Time Frame: 4 weeks ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Richard Guarino
Organization: Oxford Pharmaceutical Resources, Inc.
phone: 973-256-0600
e-mail: Guarino@oxfordpharm.com



Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT00527319     History of Changes
Other Study ID Numbers: VT-1 CAX-001
First Submitted: August 30, 2007
First Posted: September 10, 2007
Results First Submitted: November 8, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013