A Study of Xenical (Orlistat) in Overweight and Obese Ado... | NCT00940628

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

NCT00940628

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Apr 5, 2016Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Obesity

Interventions

Diet and Exercise
orlistat [Xenical]

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jun 16, 2009

First Submission Date that Met QC Criteria

Jul 15, 2009

First Posted Date

Jul 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2016

Last Update Posted Date

Apr 5, 2016Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: Diet and Exercise Drug: orlistat [Xenical]
2	Other		Behavioral: Diet and Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet and Exercise	Behavioral	mildly hypocaloric diet and physical exercise	1 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

age <12 or >14 years
BMI in normal range

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet
D015444	Exercise
D000077403	Orlistat

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Kazan'		420073	Russia