A Study of Xenical (Orlistat) in Overweight and Obese Adolescents

April 2, 2016 updated by: Hoffmann-La Roche

Open-label Comparative Randomized Study of the Efficacy and Safety of Orlistat (Xenical) in Complex Therapy of Obesity and Metabolic Disorders in Adolescents

This 2 arm study will assess the effect of Xenical on body mass index (BMI)in obese or overweight adolescents. Patients will be randomised into one of 2 groups; both groups will undergo a regimen of mildly hypocaloric diet and physical exercise, but one group will also receive Xenical 120mg po tid. The anticipated time on study treatment is 1 year, and the target sample size is <100 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
      • Kazan, Russian Federation, 420073
      • Khabarovsk, Russian Federation, 680063
      • Krasnodar, Russian Federation, 350013
      • Krasnoyarsk, Russian Federation, 660074
      • Moscow, Russian Federation, 117036
      • Nizhny Novgorod, Russian Federation, 603136
      • Novosibirsk, Russian Federation, 630048
      • Samara, Russian Federation, 443079
      • Tumen, Russian Federation, 625023
      • Yaroslavl, Russian Federation, 150030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adolescent patients, 12-14 years of age
  • overweight or obese

Exclusion Criteria:

  • age <12 or >14 years
  • BMI in normal range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: Diet and Exercise
mildly hypocaloric diet and physical exercise
Drug: orlistat [Xenical]
120mg po tid
Other: 2
Behavioral: Diet and Exercise
mildly hypocaloric diet and physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in BMI
Time Frame: At each clinic visit, every 4 weeks
At each clinic visit, every 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, laboratory parameters
Time Frame: At each clinic visit, every 4 weeks
At each clinic visit, every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 2, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19569

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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