Phentermine's Impact on Treatment in Teens
ConditionChildhood Obesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-17
SponsorRussell McCulloh, MD
About this trial
PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \<18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.
Eligibility criteria
Qualifiers
Age ≥ 12 years and < 18 years at time of consent;
Tanner Staging ≥ 2 at the time of screening;
Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg/m2);
Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
Disqualifiers
A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);
History of glaucoma;
Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;
Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);
Trial design
Treatments tested in this trial
- Phentermine
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Russell McCulloh, MD
Lead sponsor
Heartland DCOC
Sponsor institution
National Institutes of Health (NIH)
Collaborator
IDeA States Pediatric Clinical Trials Network
Collaborator
Source ClinicalTrials.gov