ObesityPhase 3NCT01535014

Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

A Phase 3 study testing Dietressa in people with Obesity, run by Materia Medica Holding at 17 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is: To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: Dietressa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 493 participants
Where: 17 sitesRussia
Study dates: 12 Dec 2011to Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient subjects with BMI 30,0-34,9 kg/m2.
Male or female subjects aged 18 to 65 inclusive.
Use of and compliance with contraception methods by patients of reproductive age, of both sexes.
Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.

Who cannot join

Symptomatic (secondary) obesity:
with established genetic defect (including as a part of known genetic syndromes affecting multiple organs): Prader-Willi syndrome, Alstrom's syndrome, Laurence-Moon-Biedl syndrome, Dercum's syndrome etc.
cerebral (adiposogenital dystrophy, Babinski-Frohlich syndrome): brain tumors; dissemination of systemic lesions, infectious diseases; against mental diseases.
endocrine: hypothyroid; hypoovarial; pituitary-hypothalamic disorders; adrenopathy.
iatrogenic (caused by drug administration, namely, insulin, glucocorticosteroids, neuroleptics etc.).
Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment.

Show all 27Show fewer

Participation in the lifestyle modification program within 6 months before enrollment.
Patients who quit smoking within 6 months before enrollment, or intending to quit smoking during the period of participation in the trial, as well as intending to begin smoking during the trial.
Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy).
Type 1 and 2 diabetes mellitus.
Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis).
Circulatory failure, IIА degree and above.
Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease.
Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial.
Past history of bulimia / non-drug abepithymia.
Past history of any bariatric surgeries.
Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit.
Surgeries scheduled within 6 months.
Allergy to/intolerance of any of the drug components used during treatment.
Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency.
Administration of drugs specified as "Prohibited concomitant therapy", within 6 months before enrollment.
Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial.
Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity.
21. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
22. Participation in other clinical trials within 3 months before enrolment in this trial.
23. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 24. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted.
25. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Russia17 sites

The State Educational institution of High Professional Training Kuban State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Clinical Pharmacology
Krasnodar, 350063
The State Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Endocrinology Faculty
Moscow, 119991
The State Budget Health Care institution of Moscow the City Clinical Hospital No. 11 of the Administration of Health Care of Moscow City
Moscow, 127018
Municipal Medical and Preventive institution "City Clinical Hospital No.10"
Nizhny Novgorod, 603011
The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"
Nizhny Novgorod, 603126
The State Educational institution of High Professional Training "Rostov State Medical University" of Ministry of Health Care and Social Development of the Russian Federation, Department of Endocrinology
Rostov-on-Don, 344022
St. Petersburg State Health Care institution "Municipal Hospital No.6"
Saint Petersburg, 191482
St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center
Saint Petersburg, 192177
The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency).
Saint Petersburg, 194291
The State Educational institution of High Professional Training "St. Petersburg State Medical University n.a. I.P. Pavlov of the Federal Agency for Health Care and Social Development", Faculty Surgery Board
Saint Petersburg, 197022
The State Educational institution of High Professional Training "St. Petersburg State Medical University n.a. I.P. Pavlov of the Federal Agency for Health Care and Social Development", Therapy Faculty Board
Saint Petersburg, 197022
St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"
Saint Petersburg, 197706
St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center
Saint Petersburg, 198260
The State Educational institution of High Professional Training "Bashkirsky State Medical University" of the Federal Agency for Health Care and Social Development, Department of Endocrinology
Ufa, 450000
The State Educational institution of High Professional Training "Volgograd State Medical University" of Ministry of Health Care and Social Development of the Russian Federation
Volgograd, 400131
The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"
Voronezh, 394018
The State Health Care institution of Yaroslavl Region the Clinical Hospital
Yaroslavl, 150062

Other trials in Russia

About this study

Official title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

The purpose of this study is:

To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients.
To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients.
To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Read the detailed description

In general, patients will be observed during 24 weeks of trial.

Conditions: Obesity
Being tested: Dietressa, Placebo
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DietressaDrug
Comparison of different dosages (frequency) of drug
PlaceboDrug
Placebo either (2 tablets 3 times daily) or
(1 tablet 6 times daily)

Study groups in NCT01535014
Study group	Role	What they receive
Dietressa (2 tablets 3 times daily) for 24 weeks	Experimental	Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks. Receives: Drug: Dietressa
Dietressa (1 tablet 6 times daily) for 24 weeks	Experimental	Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks. Receives: Drug: Dietressa
Placebo (2 tablets 3 times daily)	Placebo comparator	Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks. Receives: Drug: Placebo
Placebo (1 tablet 6 times daily)	Placebo comparator	Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Measured: assessed after 24 weeks of treatment
Average Body Weight Change After 24 Weeks of Treatment
Measured: assessed after 24 weeks of treatment
Average Relative Change in Body Weight After 24 Weeks of Treatment
Measured: assessed after 24 weeks of treatment

Secondary outcomes (4)

Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Measured: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Measured: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
Measured: assessed after 4,12 and 24 weeks of treatment
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the "physical component of health" and "mental health component". The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health.
The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score.
Measured: baseline, 4, 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 2011Jun 2013

First posted17 Feb 2012 (estimated)
Study start12 Dec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 493 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01535014
Sponsor's protocol ID: MMH-DI-002
Status last verified: Nov 2018
First submitted: 14 Feb 2012
Last updated: 28 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients
ClinicalTrials.gov ID: NCT01535014
Acronym / sponsor ID: MMH-DI-002
Conditions: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 493 participants (actual)
Lead sponsor: Materia Medica HoldingIndustry (pharma, biotech, devices)
Study start: 12 Dec 2011 (actual)
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 17 Feb 2012 (estimated)
Results: Posted 18 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is:

To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients.
To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients.
To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Detailed description

In general, patients will be observed during 24 weeks of trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Dietressa (2 tablets 3 times daily) for 24 weeks	Experimental	Drug: DietressaPatients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks.
Dietressa (1 tablet 6 times daily) for 24 weeks	Experimental	Drug: DietressaPatients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks.
Placebo (2 tablets 3 times daily)	Placebo comparator	Drug: PlaceboPatients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks.
Placebo (1 tablet 6 times daily)	Placebo comparator	Drug: PlaceboPatients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Outpatient subjects with BMI 30,0-34,9 kg/m2.
Male or female subjects aged 18 to 65 inclusive.
Use of and compliance with contraception methods by patients of reproductive age, of both sexes.
Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.

Key exclusion criteria (27 listed)

Symptomatic (secondary) obesity:
Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment.
Participation in the lifestyle modification program within 6 months before enrollment.
Patients who quit smoking within 6 months before enrollment, or intending to quit smoking during the period of participation in the trial, as well as intending to begin smoking during the trial.
Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy).

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
DietressaComparison of different dosages (frequency) of drug	Drug	Dietressa (1 tablet 6 times daily) for 24 weeks, Dietressa (2 tablets 3 times daily) for 24 weeks
PlaceboPlacebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)	Drug	Placebo (1 tablet 6 times daily), Placebo (2 tablets 3 times daily)

Primary outcome

Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Body Weight Change After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment
Average Relative Change in Body Weight After 24 Weeks of Treatment
Time frame: assessed after 24 weeks of treatment

4 secondary outcomes

Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
Time frame: assessed after 4,12 and 24 weeks of treatment
Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment
Time frame: baseline, 4, 12 and 24 weeks

Results and safety

Results posted to the registry on 18 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dietressa 1	210	208
Dietressa 2	200	194
Placebo 3	50	49
Placebo 4	33	33

Primary outcome: Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment

Time frame: assessed after 24 weeks of treatment. Number. Unit: percentage of participants

Measure	Dietressa 1 n = 208	Dietressa 2 n = 194	Placebo 3 n = 49	Placebo 4 n = 33
Value	49	48	33	21

Dietressa 1 vs Placebo 3: p = 0.04, Chi-squared
Dietressa 2 vs Placebo 4: p = 0.004, Chi-squared
Dietressa 1 vs Dietressa 2 vs Placebo 3 vs Placebo 4: p = 0.0007, Cochran-Mantel-Haenszel

Population analysed: Intention to treat

Primary outcome: Average Body Weight Change After 24 Weeks of Treatment

Time frame: assessed after 24 weeks of treatment. Mean (Standard Deviation). Unit: kilogram

Measure	Dietressa 1 n = 208	Dietressa 2 n = 194	Placebo 3 n = 49	Placebo 4 n = 33
Value	-4.4 (4.2)	-4.4 (4.4)	-3.0 (3.5)	-2.9 (2.8)

Dietressa 1 vs Placebo 3: p = 0.03, t-test, 2 sided
Dietressa 2 vs Placebo 4: p = 0.07, t-test, 2 sided

Population analysed: Intention to treat

Primary outcome: Average Relative Change in Body Weight After 24 Weeks of Treatment

Time frame: assessed after 24 weeks of treatment. Mean (Standard Deviation). Unit: percentage of body weight

Measure	Dietressa 1 n = 208	Dietressa 2 n = 194	Placebo 3 n = 49	Placebo 4 n = 33
Value	-4.9 (4.7)	-4.9 (4.9)	-3.4 (4.2)	-3.4 (3.3)

Dietressa 1 vs Placebo 3: p = 0.03, t-test, 2 sided
Dietressa 2 vs Placebo 4: p = 0.07, t-test, 2 sided

Population analysed: Intention to treat

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dietressa 1+2	3 of 410 (0.7%)	160 of 410 (39%)	Not reported
Placebo 3+4	0 of 83 (0%)	33 of 83 (39.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dietressa in people with Obesity, run by Materia Medica Holding at 17 sites in Russia.

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 4 inclusion and 27 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 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment (time frame: assessed after 24 weeks of treatment). The study lists 3 primary outcomes in all. 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 NCT01535014.

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 28 Nov 2018.