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

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ClinicalTrials.gov Identifier: NCT00806260
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : September 13, 2013
Last Update Posted : September 13, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Overweight
Obesity
Interventions: Drug: VI-0521
Drug: Placebo
Other: Alcohol
Other: alcohol placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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



Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00806260     History of Changes
Other Study ID Numbers: OB-205
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: July 31, 2012
Results First Posted: September 13, 2013
Last Update Posted: September 13, 2013