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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940628
• Other study ID #: ML19569
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2009
• Last updated: April 2, 2016
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Service on Surveillance in Healthcare and Social Development of RF
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

Inclusion Criteria:

• adolescent patients, 12-14 years of age

• overweight or obese

Exclusion Criteria:

• age <12 or >14 years

• BMI in normal range

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Diet and Exercise
mildly hypocaloric diet and physical exercise

Drug:
• orlistat [Xenical]
120mg po tid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI		At each clinic visit, every 4 weeks	No
Secondary	Adverse events, laboratory parameters		At each clinic visit, every 4 weeks	No