OverweightNCT02529631
RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
A study testing orlistat 60 mg and polyglucosamine in people with Overweight and Obesity, run by Certmedica International GmbH at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- orlistat 60 mg and polyglucosamine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2009to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 28 kg/m² and < 45 kg/m²
- Waist circumference > 80 cm (women) > 94 cm (men)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
This trial compares two treatment methods:
- 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.
- 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.
- Conditions
- Overweight, Obesity
- Being tested
- orlistat 60 mg, polyglucosamine
- Keywords
- Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orlistat 60 mgDrug
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.
polyglucosamineDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Drug: orlistat 60mg capsules | Active comparator | 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 Receives: Drug: orlistat 60 mg |
| Medical device: polyglucosamine | Active comparator | 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 Receives: Device: polyglucosamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Measured: 12 weeks
Secondary outcomes (2)
BMI reduction
Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Measured: 12 weeks
Waist circumference reduction
Achieved change of the waist circumference of all participants in each group compared to the initial average WC
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manfred Stoll, MD, Principal investigator, Diabetological centre, Dreieich, GermanyUmberto Cornelli, MD, Principal investigator, CorCon, Mailand, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529631
- Sponsor's protocol ID
- 003/07
- Status last verified
- Aug 2015
- First submitted
- 24 Jul 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoll M, Bitterlich N, Cornelli U. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. BMC Obes. 2017 Jan 11;4:4. doi: 10.1186/s40608-016-0130-4. eCollection 2017.
PubMed 28097013
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02529631
- Acronym / sponsor ID
- 003/07
- Conditions
- Overweight, Obesity
- Keywords
- Polyglucosamine, L 112, overweight,, obesity, orlistat, weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compares two treatment methods:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: orlistat 60mg capsules | Active comparator | Drug: orlistat 60 mgA 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 |
| Medical device: polyglucosamine | Active comparator | Device: polyglucosamineA 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI ≥ 28 kg/m² and < 45 kg/m²
- Waist circumference > 80 cm (women) > 94 cm (men)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orlistat 60 mgIn 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. | Drug | Drug: orlistat 60mg capsules |
| polyglucosamineIn 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). | Device | Medical device: polyglucosamine |
Primary outcome
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Time frame: 12 weeks
2 secondary outcomes
BMI reduction
Time frame: 12 weeks
Waist circumference reduction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 28097013Stoll M, Bitterlich N, Cornelli U. Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity. BMC Obes. 2017 Jan 11;4:4. doi: 10.1186/s40608-016-0130-4. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Stoll, MD principal investigator
Diabetological centre, Dreieich, Germany
Umberto Cornelli, MD principal investigator
CorCon, Mailand, Italy
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orlistat 60 mg and polyglucosamine in people with Overweight and Obesity, run by Certmedica International GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.