A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00806260
First received: December 9, 2008
Last updated: August 1, 2013
Last verified: August 2013
Results First Received: July 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Overweight
Obesity
Interventions: Drug: VI-0521
Drug: Placebo
Other: Alcohol
Other: alcohol placebo

  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
Subject recruitment occurred within the US between January 2009 and March 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Period 1 was not a crossover design. Subjects were randomized to either alcohol or alcohol-placebo. Subjects who completed Period 1 were then randomized to the crossover portion of the study, Periods 2 and 3.

Reporting Groups
  Description
Alcohol, VI-0521 Placebo Then VI-0521 Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
Alcohol, VI-0521 Then VI-0521 Placebo Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
Alcohol-placebo, VI-0521-placebo Then VI-0521 Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
Alcohol-placebo, VI-0521 Then VI-0521-placebo Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
Alcohol Only Alcohol was administered during period one after which the subject's participation ended.
Alcohol-placebo Only Alcohol-placebo was administered during period one after which the subject's participation ended.

Participant Flow for 3 periods

Period 1:   Period 1 (1 Day)
    Alcohol, VI-0521 Placebo Then VI-0521     Alcohol, VI-0521 Then VI-0521 Placebo     Alcohol-placebo, VI-0521-placebo Then VI-0521     Alcohol-placebo, VI-0521 Then VI-0521-placebo     Alcohol Only     Alcohol-placebo Only  
STARTED     15     8     8     14     18     17  
COMPLETED     15     8     8     14     15 [1]   17 [1]
NOT COMPLETED     0     0     0     0     3     0  
Adverse Event                 0                 0                 0                 0                 3                 0  
[1] did not move onto Periods 2 and 3 due to adjusted design of study

Period 2:   Period 2
    Alcohol, VI-0521 Placebo Then VI-0521     Alcohol, VI-0521 Then VI-0521 Placebo     Alcohol-placebo, VI-0521-placebo Then VI-0521     Alcohol-placebo, VI-0521 Then VI-0521-placebo     Alcohol Only     Alcohol-placebo Only  
STARTED     15     8     8     14     0     0  
COMPLETED     13     8     6     12     0     0  
NOT COMPLETED     2     0     2     2     0     0  
Adverse Event                 0                 0                 0                 1                 0                 0  
Protocol Violation                 1                 0                 1                 0                 0                 0  
Need to take concomitant medication                 1                 0                 0                 0                 0                 0  
sponsor request                 0                 0                 1                 1                 0                 0  

Period 3:   Period 3
    Alcohol, VI-0521 Placebo Then VI-0521     Alcohol, VI-0521 Then VI-0521 Placebo     Alcohol-placebo, VI-0521-placebo Then VI-0521     Alcohol-placebo, VI-0521 Then VI-0521-placebo     Alcohol Only     Alcohol-placebo Only  
STARTED     13     8     6     12     0     0  
COMPLETED     12     7     5     12     0     0  
NOT COMPLETED     1     1     1     0     0     0  
Protocol Violation                 0                 1                 1                 0                 0                 0  
Pregnancy                 1                 0                 0                 0                 0                 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
Alcohol, VI-0521 Placebo Then VI-0521 Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
Alcohol, VI-0521 Then VI-0521 Placebo Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
Alcohol Placebo, VI-0521 Placebo Then VI-0521 Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
Alcohol Placebo, VI-0521 Then VI-0521 Placebo Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
Alcohol Only Subjects in this study arm only participated in period 1 and were given alcohol.
Alcohol Placebo Only Subject in this study arm only participated in period 1 and were given alcohol placebo.
Total Total of all reporting groups

Baseline Measures
    Alcohol, VI-0521 Placebo Then VI-0521     Alcohol, VI-0521 Then VI-0521 Placebo     Alcohol Placebo, VI-0521 Placebo Then VI-0521     Alcohol Placebo, VI-0521 Then VI-0521 Placebo     Alcohol Only     Alcohol Placebo Only     Total  
Number of Participants  
[units: participants]
  15     8     8     14     18     17     80  
Age  
[units: years]
Mean ± Standard Deviation
  26.7  ± 5.4     29.9  ± 7.8     31.1  ± 8.6     27.4  ± 6.1     30.1  ± 7.7     27.4  ± 6.3     28.5  ± 6.8  
Gender  
[units: participants]
             
Female     5     1     1     6     7     1     21  
Male     10     7     7     8     11     16     59  
Region of Enrollment  
[units: participants]
             
United States     15     8     8     14     18     17     80  



  Outcome Measures
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1.  Primary:   Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.   [ Time Frame: at breath alcohol levels 0.10%, 0.07%, and 0.04% ]

2.  Primary:   Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.   [ Time Frame: Hour 2 and Hour 6 ]


  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
Due to technical issues, an additional cohort of subjects were added to Period 1 only, which produced two additional treatment arms, alcohol only and alcohol placebo only. No change was made in the data analysis.


  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: Wesley W Day, PhD
Organization: Vivus, Inc.
phone: 650-934-5200
e-mail: day@vivus.com


No publications provided


Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00806260     History of Changes
Other Study ID Numbers: OB-205
Study First Received: December 9, 2008
Results First Received: July 31, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration