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Qsymia for Childhood Obesity
Study Summary
This trial demonstrated that phentermine/topiramate results in clinically meaningful and durable weight loss in adults with obesity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I speak English or Spanish.I have been treated with growth hormone in the past.I have used weight loss medication in the last 6 months.I have a history of glaucoma.My kidney function is moderately or severely impaired.I have had gallstones in the past.You have a history of attempting suicide or currently have thoughts or plans to harm yourself.My BMI is in the top 5% for my age and sex.I have a heart defect or a serious irregular heartbeat.I haven't started or changed the dose of any weight-altering medication in the last 6 months.I have a history of seizures.You have recently had thoughts of hurting yourself or have engaged in self-harm within the past month.My blood pressure is high, measured three times.I am currently taking sulfonylurea medications.I have had weight loss surgery in the past.I have had kidney stones in the past.You have a known allergy or sensitivity to certain types of medications that mimic the effects of adrenaline.You currently smoke cigarettes or use other tobacco products.I am between 12 and 20 years old.I have been diagnosed with an overactive thyroid.I have used a monoamine oxidase inhibitor or carbonic anhydrase inhibitor in the last 14 days.My thyroid disorder is untreated or my TSH levels are very low.My liver disease is moderate to severe.You have any condition or situation that the researcher believes could potentially harm you during the study.I have severe depression, diagnosed or with a PHQ-9 score of 15 or higher.I am currently taking medication that stimulates my body.You have a history of bulimia nervosa, a condition where you frequently eat large amounts of food and then try to get rid of it.I have been diagnosed with obesity caused by a single gene.
- Group 1: Placebo-Controlled Period
- Group 2: Open Label Extension
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Have any other experimental protocols included Phentermine/Topiramate (Qsymia)?
"At the moment, 19 clinical trials for Phentermine/Topiramate (Qsymia) are in progress with 3 of them being at Phase 3. The majority of these studies take place within Sherbrooke, Quebec but there are still 35 other medical sites running experiments on this medication."
Is participation in this research study available to those who qualify?
"Per information published on clinicaltrials.gov, this trial is presently recruiting patients; the project was posted to the website on July 7th 2022 and most recently updated on September 21st 2022."
What qualifications must a participant possess to join this research project?
"To be included in this trial, adolescents aged between 12 and 20 with pediatric obesity are eligible. The total number of individuals being accepted into the study is 30."
To what health concerns is Phentermine/Topiramate (Qsymia) typically prescribed?
"Phentermine/Topiramate (Qsymia) is commonly prescribed to treat tonic-clonic seizures, lipidemia, Lennox Gastaut Syndrome (LGS), and Type 2 diabetes Mellitus."
Is eligibility for this trial restricted to individuals aged 18 or above?
"This trial is open to participants between the ages of 12-20. As per clinicaltrials.gov, there are 257 medical trials for minors and 613 studies catering to elderly patients."
How many people are participating in this clinical experiment?
"Affirmative. Per clinicaltrials.gov, this research project is currently recruiting participants. The trial was initially listed on July 7th 2022 and the details were most recently updated on September 21st 2022. Thirty subjects are needed to be enrolled from one location."
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