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Trial record 11 of 69 for:    ORLISTAT

RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity

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ClinicalTrials.gov Identifier: NCT02529631
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Certmedica International GmbH

Brief Summary:

This trial compares two treatment methods:

  1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in overweight adults. Important is also that it is taken along with a reduced-calorie and low-fat diet.
  2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main meals with the highest fat content, indicated for weight maintenance and weight loss.

Condition or disease Intervention/treatment Phase
Overweight Obesity Drug: orlistat 60 mg Device: polyglucosamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arm Intervention/treatment
Active Comparator: Drug: orlistat 60mg capsules

A tailored blister-strip for one day contains

  • three capsules with orlistat 60mg Administration: 3 times daily 1 capsule with each meal containing fat concomitant with
  • six placebo tablets Administration: 3 times daily 2 tablets with each main meal
Drug: orlistat 60 mg

In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.

Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets.


Active Comparator: Medical device: polyglucosamine

A tailored blister-strip for one day contains

  • three placebo capsules Administration: 3 times daily 1 capsule with each meal containing fat concomitant with
  • six tablets Administration: 3 times daily 2 tablets (whereas the 2 tablets in the mold "breakfast" are placebo tablets and the remaining 4 tablets for lunch and dinner contains poliglucosamine
Device: polyglucosamine

In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.

Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).





Primary Outcome Measures :
  1. Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. BMI reduction [ Time Frame: 12 weeks ]
    Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI

  2. Waist circumference reduction [ Time Frame: 12 weeks ]
    Achieved change of the waist circumference of all participants in each group compared to the initial average WC



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 28 kg/m² and < 45 kg/m²
  • Waist circumference > 80 cm (women) > 94 cm (men)

Exclusion Criteria:

  • Energy intake lower than the standard value according to Miffin St-Jeor equation
  • Pregnancy or breast-feeding
  • Addiction to alcohol
  • Inability to fulfil the requirement of the trial protocol
  • Cancer ,malignant tumour
  • Hypersensitivity reactions to crustaceans or ingredient of the study medication
  • Chronic diseases not under control with adequate therapy
  • Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529631


Locations
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Germany
Diabetological Center
Dreieich, Hesse, Germany, 63303
Italy
MAP Center
Rende, Cosenza, Italy, 87036
Sponsors and Collaborators
Certmedica International GmbH
Investigators
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Principal Investigator: Manfred Stoll, MD Diabetological centre, Dreieich, Germany
Principal Investigator: Umberto Cornelli, MD CorCon, Mailand, Italy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Certmedica International GmbH
ClinicalTrials.gov Identifier: NCT02529631     History of Changes
Other Study ID Numbers: 003/07
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by Certmedica International GmbH:
Polyglucosamine
L 112
overweight,
obesity
orlistat
weight reduction
Additional relevant MeSH terms:
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Orlistat
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents