Status:
COMPLETED
Safety and Efficacy of Litramine in Overweight and Obese Subjects
Lead Sponsor:
InQpharm Group
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell ...
Eligibility Criteria
Inclusion
- 25 ≤ BMI ≤ 35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Consistent and stable body weight 3 months prior to study enrolment
- Commitment to avoid the use of other weight loss products during study
- Commitment to adhere to diet recommendation
- Females' agreement to use appropriate birth control methods during the active study period
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion
- Known sensitivity to the ingredients of the device
- Presence of any active gastrointestinal disease
- Malabsorption disorders (e.g. Coeliac disease)
- Pancreatitis
- Stenosis in the GI tract
- Bariatric surgery
- Abdominal surgery within the last 6 months prior to the study
- History of eating disorders like bulimia, anorexia nervosa
- History of renal disease
- History of nephrolithiasis
- History of cardiac diseases
- Osteoporosis
- Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus
- Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start)
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.)
- More than 3 hours serious sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within the 6 months prior to this study
- Inability to comply due to language difficulties
- Participation in similar studies or weight loss programs within the 6 months prior to this study
- Participation in other studies within the last 4 weeks
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01233349
Start Date
July 1 2010
End Date
January 1 2011
Last Update
October 13 2011
Active Locations (1)
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1
Barbara Grube
Berlin, Germany