A Pharmacokinetic Study to Compare the Dosing of Valproic... | NCT00298857

Studies
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

NCT00298857

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Jul 3, 2012Estimated

Enrollment

Phase

Phase 4

Conditions

Healthy
Obesity
Pharmacokinetics

Interventions

Valproic acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Mar 2, 2006

First Submission Date that Met QC Criteria

Mar 2, 2006

First Posted Date

Mar 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2012

Last Update Posted Date

Jul 3, 2012Estimated

Description Module

Brief Summary

The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.

Detailed Description

Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Valproic acid	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female age 21-60 years
Normal healthy volunteers as per interview at screening
Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

Inability to take oral medications
pregnant or lactating females
known hypersensitivity to valproic acid
BMI less than 18.5 kg/m^2
BMI between 25 and 29.9 kg/m^2, inclusive
Taking any drug or dietary supplement within one week prior to study period
Consumption of food 6 hours prior to study drug ingestion
Know family history or history of urea cycle disorders
Past history of pancreatitis
Past history of liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alan Ettinger, MD	North Shore - Long Island Jewish Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Long Island Jewish Medical Center		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided