Status:
COMPLETED
Efficacy and Safety of Glucosanol in Maintaining Body Weight
Lead Sponsor:
InQpharm Group
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess t...
Eligibility Criteria
Inclusion
- Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
- Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
- BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
- Expressed desire for weight maintenance
- Accustomed to 3 main meals per day
- Commitment to avoid the use of other weight loss products during study
- 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 (Phaseolus vulgaris or members of the Fabaceae family)
- History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
- History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders)
- Clinically relevant excursions of safety parameter
- Current use of anti-depressants
- Presence of acute or chronic gastrointestinal disease (e.g. IBD, coeliac disease, pancreatitis)
- Uncontrolled hypertension (more than 160/110 mm Hg)
- Stenosis in the GI tract
- Bariatric surgery
- Abdominal surgery within the last 6 months prior to enrollment
- History of eating disorders like bulimia, anorexia nervosa within the past 12 months
- Other serious organ or systemic diseases such as cancer
- Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
- More than 3 hours strenuous sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within 6 months prior to enrolment
- Inability to comply due to language difficulties
- Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01435278
Start Date
September 1 2011
End Date
July 1 2012
Last Update
July 27 2012
Active Locations (1)
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1
Barbara Grube, MD
Berlin, Germany