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ObesityPhase 3NCT00261911

A Study of Sibutramine in Overweight Adolescents to Assess Weight Loss and Safety.

A Phase 3 study testing sibutramine in people with Obesity, run by Abbott.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the effectiveness of sibutramine on weight loss, reduction in body size and improvement in metabolic risk factors and safety in obese adolescents. Read more about this study

Who is it for?
Ages 12 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
sibutramine
How many people
498 participants
Where
No sites listed yet
Study dates
Jul 2000to Feb 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Obese adolescent males and females in good general health with a lower limit of inclusion by BMI 2 units above the U.S. weighted mean for the 95th percentile for weight based on age and gender to a BMI of 44 kg/m2, ages 12 to 16 years at randomization. (Efforts should be directed to obtain a study population comprising 50% to 75% females and at least 30% African- Americans across the study. Each site should enroll similar numbers of patients at each age within the 12 to 16 year old age range.)
  • Both the patient and legal guardian/parent must be able to communicate meaningfully with the investigator, be legally competent, and provide written informed consent/assent.
  • All patients must exhibit sufficient comprehension of written materials to be able to follow diet and exercise recommendations, and to complete written behavioral assessments.
  • For females of childbearing potential, a negative pregnancy test will be required prior to study inclusion. Female patients, if sexually active, must be using adequate contraceptive precautions (i.e., oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide). Oral contraceptive use is permitted if used for at least 3 months before starting study medication.
  • A serum pregnancy test, which must be negative, is required of all females.
  • The patient must have at the screening and baseline visits a mean systolic blood pressure <=130 mm Hg, a diastolic blood pressure <=85 mm Hg, and a pulse rate <=95 beats per minute. Treated hypertensives are allowed in the study if medication has been stable for at least 3 months.

Who cannot join

  • The patient must not have a history of anorexia nervosa.
  • The patient must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
  • The patient must not have a history of stroke.
  • The patient must not have a history of asthma requiring chronic oral corticosteroid therapy. A short course (<7 days) of oral corticosteroid medication is permitted for an acute exacerbation.
  • The patient must not have a history of narrow angle glaucoma.
  • The patient must not have a history of gallstones unless status post cholecystectomy.
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  • The patient must not have a history of seizures with the exception of childhood febrile seizure.
  • The patient must not have evidence of possible renal dysfunction (creatinine >1.7 mg/dL) or hepatic dysfunction (ALT >50 IU/L, bilirubin >1.0 mg/dL). Patients must not have evidence of active or chronic Hepatitis B or C infection.
  • The patient must not be using any of the following medications at any time during the study: monoamine oxidase inhibitors (e.g., furazolidone, phenelzine, procarbazine hydrochloride, selegiline), antidepressant agents (including the use of antidepressant agents for more than 2 weeks during the 90 day period prior to screening), lithium, serotonin reuptake inhibitors, certain opioids (dextromethorphan, meperidine, pentazocine, and fentanyl), prescribed or over-the-counter weight loss agents, centrally acting appetite suppressants, tryptophan, sympathomimetics, serotonergic anti-migraine agents (including sumatriptan succinate, dihydroergotamine, etc.) or any other medication that, in the opinion of the Investigator, may pose harm to the patient, obscure the effects of study medication or interfere with the process of drug absorption, distribution, metabolism, or excretion (i.e., enzyme inducers or enzyme inhibitors).
  • Patients may not be taken off an antidepressant for the purposes of entering this study.
  • The patient and parent/legal guardian must not have a history of alcohol or drug addiction or substance abuse within the previous two years.
  • Patients must not be above the 95th percentile for gender and age for the following categories at Screening, as assessed by the Child Behavior CheckList: "thought problems", "delinquent behavior", "aggressive behavior", or "attention problems".
  • The patient must not have a t-score of greater than 65 (significantly above average) for the total Child Depression Inventory score.
  • The patient must not have participated in rigorous, structured weight loss programs for more than 2 weeks within the past 6 months prior to screening. Continuing participation in less rigorous programs such as Weight Watchers is allowed; however, the patients must have been a participant for at least 6 months prior to screening to be allowed in the study.
  • The patient must not have participated in any investigational drug study within thirty (30) days prior to screening.
  • The patient must not have used prescription or OTC (or herbal) weight control medication for more than two (2) weeks during the 180 day period immediately preceding screening. In addition, any such medication is not allowed in the trial.
  • The patient must not have previously been a patient/subject in a sibutramine trial or have otherwise used sibutramine.
  • Pregnancy
  • Pathophysiologic or genetic syndromes associated with obesity (Cushing's syndrome, Turner's syndrome, Prader-Willi syndrome; etc.)
  • Diabetes mellitus (FBG greater than or equal to 126 mg/dL)
  • Untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test)
  • Malignancy
  • Patient must not have drug screen positive for recreational drugs.
  • Coagulopathies or bleeding disorders
  • Gastric bypass or other surgical procedure which has the potential to interfere with absorption of study medication, or gastric restrictive surgery.
  • Major psychiatric illness in either the patient or patient's legal guardian/parent(s) such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, psychosis; etc.
  • Failure to maintain a minimum level of academic achievement during the previous 6 months prior to screening (patients are excluded if receiving multiple failing grades in school).
  • Any other severe medical or psychiatric disorder that precludes participation.

About this study

Official title: A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescents

The purpose of this study is to assess the effectiveness of sibutramine on weight loss, reduction in body size and improvement in metabolic risk factors and safety in obese adolescents.

Conditions
Obesity
Being tested
sibutramine
Keywords
Meridia, Sibutramine, Obesity, Adolescent, BMI
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sibutramineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change in body mass index (BMI) from baseline to endpoint.

    Measured: 12 months

Secondary outcomes (5)

  1. Percent change from Baseline in BMI

    Measured: 12 months

  2. Proportions of subjects achieving >= 5% and >=10% BMI and body weight reduction

    Measured: 12 months

  3. Absolute and percent change from Baseline in waist circumference

    Measured: 12 months

  4. Body composition (DXA)

    Measured: 12 months

  5. Lipid and glycemic variables

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startJul 2000
  3. Study completionFeb 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00261911
Sponsor's protocol ID
SB238
Status last verified
Aug 2007
First submitted
2 Dec 2005
Last updated
31 Aug 2007
Results posted
No
Data monitoring committee
No

Publications

  • Berkowitz RI, Fujioka K, Daniels SR, Hoppin AG, Owen S, Perry AC, Sothern MS, Renz CL, Pirner MA, Walch JK, Jasinsky O, Hewkin AC, Blakesley VA; Sibutramine Adolescent Study Group. Effects of sibutramine treatment in obese adolescents: a randomized trial. Ann Intern Med. 2006 Jul 18;145(2):81-90. doi: 10.7326/0003-4819-145-2-200607180-00005.

    PubMed 16847290

  • Daniels SR, Long B, Crow S, Styne D, Sothern M, Vargas-Rodriguez I, Harris L, Walch J, Jasinsky O, Cwik K, Hewkin A, Blakesley V; Sibutramine Adolescent Study Group. Cardiovascular effects of sibutramine in the treatment of obese adolescents: results of a randomized, double-blind, placebo-controlled study. Pediatrics. 2007 Jul;120(1):e147-57. doi: 10.1542/peds.2006-2137. Epub 2007 Jun 18.

    PubMed 17576783

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sibutramine in people with Obesity, run by Abbott.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change in body mass index (BMI) from baseline to endpoint. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00261911, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2007.

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