Anti-Obesity Phentermine-Topiramate Extended Release Pharmacotherapy vs Placebo Among Patients Using a Wearable Activity Tracker
NCT ID: NCT04408586
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2020-06-03
2022-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phentermine - Topiramate Extended Release group
Phentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Placebo Group
Placebo
Placebo looks exactly like the study drug, but it contains no active ingredient
Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Interventions
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Phentermine-Topiramate Extended Release
Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
Placebo
Placebo looks exactly like the study drug, but it contains no active ingredient
Online support system
VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 18-75 years.
* Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment.
* Women of childbearing potential must agree to use a method of effective contraception during study participation.
* Subject must have an Apple iPhone 6s or later with iOS 13 or later and be willing to download the VitalCare (VitalTech Affiliates LLC) application from the Apple App Store.
* Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
Exclusion Criteria
* Weight is greater than 450 lbs (204 kg)
* Recent use (within the last three months) of any antiobesity medication
* Recent weight change (gain or loss weight greater than 3% TBW in the last 3 months)
* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.
* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
* Hypersensitivity or contraindication to the study medication.
* Participant unable or unwilling to follow protocol including use of the wearable activity tracker, digital wellness devices, VitalCare application, or unwilling to sign consent.
* Principal Investigator discretion
18 Years
75 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Andres Acosta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-011697
Identifier Type: -
Identifier Source: org_study_id
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