A Study Using DNA Samples From Patients Who Participated in Previous Topiramate Obesity and Type 2 Diabetes Studies - Tabular View

Tracking Information

First Received Date ^ICMJE

March 17, 2006

Last Updated Date

March 21, 2008

Start Date ^ICMJE

April 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00304603 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study Using DNA Samples From Patients Who Participated in Previous Topiramate Obesity and Type 2 Diabetes Studies

Official Title ^ICMJE

A Study to Evaluate the Mode of Action of Topiramate in the Treatment of Obese Subjects With and Without Type 2 Diabetes Mellitus Using DNA Samples From Subjects Who Were Randomized Within Select Previous Topiramate Studies

Brief Summary

The purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chromosomes and the clinical outcomes.

Detailed Description

Previous studies suggest that genetic factors may play a significant role in determining the amount of weight loss in response to pharmacological treatment. Topiramate is not approved for the treatment of obesity, but reported weight changes in response to treatment with topiramate may be linked to genetic factors. This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from subjects who were randomized in 1 of 3 previous topiramate studies on obesity and diabetes. The study consist of a screening telephone contact, a single visit to the study site for a blood sample collection (10ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event-reporting period. The goal of the study is to identify genes that impact percent change in weight and HbA1c from baseline at Week 24 (of the selected studies) and the occurrence of the most frequent central nervous system (CNS)-related adverse events in response to topiramate. The study hypothesis is that there are certain types of genes that are involved in the mode of action of topiramate.

No study drug was administered.

Study Phase

Phase III

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Retrospective

Condition ^ICMJE

Diabetes Mellitus, Type 2
Obesity

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1140

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient must have been randomized within the select previous topiramate obesity and diabetes studies: CR003721 or CR003712 or a subset of subjects with diabetes mellitus who were randomized within the CR003718 study at sites that also participated in the CR003721

Exclusion Criteria:

Patient must have been randomized within the select previous topiramate obesity and diabetes studies: CR003721 or CR003712 or a subset of subjects with diabetes mellitus who were randomized within the CR003718 study at sites that also participated in the CR003721

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00304603

Responsible Party

Study ID Numbers ^ICMJE

CR003409

Study Sponsor ^ICMJE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information Provided By

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Verification Date

March 2008

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