Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-06-01
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medication Group
Adolescent patients post vertical sleeve gastrectomy who have had inadequate weight loss, who consented for use of off-label medications prescribed at the discretion (one or both) of physician.
Patients will be followed every 2-12 weeks over one year.
All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
Topiramate
Topiramate (starting dose 25 mg daily, max dose 100 mg daily)
Phentermine
Phentermine (starting dose 8 mg, max dose 16 mg)
Non-Medication Group
Adolescent patients post vertical sleeve gastrectomy who had inadequate weight loss and did not consent for use of off-label medications.
All patients in this group will continue to follow the standard of care procedures of our multidisciplinary bariatric clinic, including frequent follow-up appointments, nutrition guidance, vitamin supplementation, exercise instruction, and healthy lifestyle education.
No interventions assigned to this group
Interventions
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Topiramate
Topiramate (starting dose 25 mg daily, max dose 100 mg daily)
Phentermine
Phentermine (starting dose 8 mg, max dose 16 mg)
Eligibility Criteria
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Inclusion Criteria
* Inadequate weight loss after vertical sleeve gastrectomy
Exclusion Criteria
* Unwilling to consent or adhere to safety monitoring plan;
* Any life-threatening or terminal diseases
* Currently pregnant, breastfeeding, or thinking of becoming pregnant
* Allergy or medical contraindication to phentermine or topiramate;
* History of drug or alcohol abuse;
* No known medication interactions;
* Significant renal or hepatic impairment;
* Participation in a study of an investigational medication 30 days prior to screening, while the patient is on study, and for 30 days after their last dose of study treatment
12 Years
25 Years
ALL
No
Sponsors
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Maternal and Child Health Research Institute
UNKNOWN
Janey Pratt
OTHER
Responsible Party
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Janey Pratt
Clinical Associate Professor of Surgery
Principal Investigators
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Janey Pratt, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Countries
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References
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Aldenkamp AP, Baker G, Mulder OG, Chadwick D, Cooper P, Doelman J, Duncan R, Gassmann-Mayer C, de Haan GJ, Hughson C, Hulsman J, Overweg J, Pledger G, Rentmeester TW, Riaz H, Wroe S. A multicenter, randomized clinical study to evaluate the effect on cognitive function of topiramate compared with valproate as add-on therapy to carbamazepine in patients with partial-onset seizures. Epilepsia. 2000 Sep;41(9):1167-78. doi: 10.1111/j.1528-1157.2000.tb00322.x.
Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005 Mar 17;352(11):1112-20. doi: 10.1056/NEJMra041867. No abstract available.
Chanoine JP, Richard M. Early weight loss and outcome at one year in obese adolescents treated with orlistat or placebo. Int J Pediatr Obes. 2011 Apr;6(2):95-101. doi: 10.3109/17477166.2010.519387. Epub 2010 Sep 22.
Czepiel KS, Perez NP, Campoverde Reyes KJ, Sabharwal S, Stanford FC. Pharmacotherapy for the Treatment of Overweight and Obesity in Children, Adolescents, and Young Adults in a Large Health System in the US. Front Endocrinol (Lausanne). 2020 May 13;11:290. doi: 10.3389/fendo.2020.00290. eCollection 2020.
Doose DR, Wang SS, Padmanabhan M, Schwabe S, Jacobs D, Bialer M. Effect of topiramate or carbamazepine on the pharmacokinetics of an oral contraceptive containing norethindrone and ethinyl estradiol in healthy obese and nonobese female subjects. Epilepsia. 2003 Apr;44(4):540-9. doi: 10.1046/j.1528-1157.2003.55602.x.
Hendricks EJ, Srisurapanont M, Schmidt SL, Haggard M, Souter S, Mitchell CL, De Marco DG, Hendricks MJ, Istratiy Y, Greenway FL. Addiction potential of phentermine prescribed during long-term treatment of obesity. Int J Obes (Lond). 2014 Feb;38(2):292-8. doi: 10.1038/ijo.2013.74. Epub 2013 May 17.
Kramer CK, Leitao CB, Pinto LC, Canani LH, Azevedo MJ, Gross JL. Efficacy and safety of topiramate on weight loss: a meta-analysis of randomized controlled trials. Obes Rev. 2011 May;12(5):e338-47. doi: 10.1111/j.1467-789X.2010.00846.x. Epub 2011 Mar 28.
Lewis KH, Fischer H, Ard J, Barton L, Bessesen DH, Daley MF, Desai J, Fitzpatrick SL, Horberg M, Koebnick C, Oshiro C, Yamamoto A, Young DR, Arterburn DE. Safety and Effectiveness of Longer-Term Phentermine Use: Clinical Outcomes from an Electronic Health Record Cohort. Obesity (Silver Spring). 2019 Apr;27(4):591-602. doi: 10.1002/oby.22430.
Ahamada Safna Mariyam M, Sen S, Vijayan K. Topiramate: Safety in migraine patients. J Young Pharm. 2013 Mar;5(1):30-1. doi: 10.1016/j.jyp.2012.12.001. Epub 2013 Mar 6. No abstract available.
Martin R, Kuzniecky R, Ho S, Hetherington H, Pan J, Sinclair K, Gilliam F, Faught E. Cognitive effects of topiramate, gabapentin, and lamotrigine in healthy young adults. Neurology. 1999 Jan 15;52(2):321-7. doi: 10.1212/wnl.52.2.321.
Rich S, Rubin L, Walker AM, Schneeweiss S, Abenhaim L. Anorexigens and pulmonary hypertension in the United States: results from the surveillance of North American pulmonary hypertension. Chest. 2000 Mar;117(3):870-4. doi: 10.1378/chest.117.3.870.
Rissanen A, Lean M, Rossner S, Segal KR, Sjostrom L. Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines. Int J Obes Relat Metab Disord. 2003 Jan;27(1):103-9. doi: 10.1038/sj.ijo.0802165.
Other Identifiers
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1092951-100- KHAAX
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
54967
Identifier Type: -
Identifier Source: org_study_id
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