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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: September 13, 2011
Last verified: September 2011
History of Changes

December 9, 2008
September 13, 2011
December 2008
May 2009   (final data collection date for primary outcome measure)
Measure of psychomotor function using speed and coordination on the CogScreen Pathfinder Number Test, assessed by reaction time for correct responses and coordination error, in subjects treated with VI-0521 compared to placebo. [ Time Frame: Beginning, middle, end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806260 on ClinicalTrials.gov Archive Site
Additional measures of psychomotor function supporting the primary endpoint including: Reaction time, attention, and information processing speed [ Time Frame: Beginning, middle, end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.

The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Drug: VI-0521
    Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week
  • Drug: Placebo
    Placebo daily for 4 weeks
  • Other: Alcohol or fruit juice
    Single dose of alcohol or fruit juice
  • Experimental: 1
    VI-0521 (Phentermine and topiramate)
    Intervention: Drug: VI-0521
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 3
    Subjects will be given either alcohol or fruit juice.
    Intervention: Other: Alcohol or fruit juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written consents;
  • Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
  • Healthy obese or overweight subjects with BMI between 27 and 35.

Exclusion Criteria:

  • History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
  • Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
  • History of drug abuse during the three years prior to screening;
  • History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
  • Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
  • More than one lifetime episode of major depression;
  • Currently working night shifts at a job;
  • On average consumes greater than two cups of coffee or xanthine-containing beverages per day (>200 mg/day) within the two weeks prior to screening;
  • Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
  • Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;
  • Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00806260
OB-205
No
VIVUS, Inc.
VIVUS, Inc.
MDS Pharma Services
Study Director: Craig Peterson VIVUS, Inc.
Principal Investigator: Alan Marion, MD MDS Pharma Services
VIVUS, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP