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A Study Using DNA Samples From Patients Who Participated in Previous Topiramate Obesity and Type 2 Diabetes Studies
This study has been completed.

First Received on March 17, 2006.   Last Updated on March 21, 2008   History of Changes
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00304603
  Purpose

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.


Condition Phase
Diabetes Mellitus, Type 2
Obesity
Phase III

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Estimated Enrollment: 1140
Study Start Date: April 2004
Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304603

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00304603     History of Changes
Other Study ID Numbers: CR003409
Study First Received: March 17, 2006
Last Updated: March 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
DNA Polymorphism
Obesity
Type 2 Diabetes Mellitus
Pharmacogenomics
Topiramate

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 09, 2012