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

Sponsor:	VIVUS, Inc.
Collaborator:	MDS Pharma Services
Information provided by:	VIVUS, Inc.
ClinicalTrials.gov Identifier:	NCT00806260

Purpose

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.

Condition	Intervention	Phase
Overweight Obesity	Drug: VI-0521 Drug: Placebo Other: Alcohol or fruit juice	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine Obesity

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	December 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental VI-0521 (Phentermine and topiramate)	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
2: Placebo Comparator Placebo	Drug: Placebo Placebo daily for 4 weeks
3: Active Comparator Subjects will be given either alcohol or fruit juice.	Other: Alcohol or fruit juice Single dose of alcohol or fruit juice

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806260

Locations

United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68502

Sponsors and Collaborators

VIVUS, Inc.

MDS Pharma Services

Investigators

Study Director:	Craig Peterson	VIVUS, Inc.
Principal Investigator:	Alan Marion, MD	MDS Pharma Services

More Information

No publications provided

Responsible Party:	Vivus, Inc. ( Wesley Day, VP Clinical )
Study ID Numbers:	OB-205
Study First Received:	December 9, 2008
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00806260 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:

Overweight
Obesity
coordination
psychomotor

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on February 08, 2010