Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults

Obesity Clinical Trial

Official title:

Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706067
• Other study ID #: ML16868
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2016
• Last updated: April 2, 2016
• Start date: July 2002
• Est. completion date: March 2009

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of a multifactorial approach associated with orlistat (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination with diet, physical activity, and/or cognitive behavioral therapy will be monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) greater than or equal to (>/=) 30 kilograms per meter-squared (kg/m^2), or BMI >/= 28 kg/m^2 with risk factors of diabetes, hypertension, or hyperlipidemia, before weight loss

• Documented weight loss >/= 10% of initial body weight obtained with diet, with or without psychological therapy or orlistat

Exclusion Criteria:

• Pregnant or lactating females

• History or presence of significant medical disorders

• Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes

• Pancreatic disease: pancreatic enzyme deficiency, history or current presence of pancreatitis

• Clinically significant abnormal clinical chemistry or hematology results

• Excessive alcohol intake

• Smoking cessation within the previous 6 months

• History or presence of cancer

• Administration of medicines known to alter body weight

• History or presence of cancer

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• Orlistat
Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight at Year 2		Baseline and Year 2
Primary	Percent Change from Baseline in Body Weight at Year 4		Baseline and Year 4
Secondary	Percentage of Participants Diagnosed with Binge Eating Disorder According to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Criteria		Every 6 months during Year 1, annually during Years 2 to 4
Secondary	Eating Disorder Inventory (EDI) 2 Subscale and Total Score		Baseline and Year 4
Secondary	Hospital Anxiety and Depression (HAD) Subscale Score		Baseline and Year 4
Secondary	Number of Orlistat Capsules Taken During the Study		Given up to three times per day for 4 years
Secondary	Duration of Orlistat Treatment During the Study		Given up to three times per day for 4 years
Secondary	Waist-to-Hip Circumference Ratio		Baseline and Year 4
Secondary	Waist, Hip, Wrist, and Arm Circumference (Expressed in Centimeters)		Baseline and Year 4
Secondary	Skinfold Thickness (Expressed in Millimeters)		Baseline and Year 4
Secondary	Bioelectrical Impedance (Expressed in Kilograms of Body Fat Mass)		Baseline and Year 4
Secondary	Number of Kilocalories Expended, Total and at Rest		Baseline and Year 4