Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In general, patients will be observed during 24 weeks of trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietressa | Experimental | Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. |
|
| Placebo | Placebo Comparator | Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietressa | Drug | Oral administration. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With at Least 5% Weight Loss. | Based on medical records. | 24 weeks |
| Average Absolute Weight Change | Based on medical records. | On baseline and after 24 weeks |
| Average Relative Weight Change | Based on medical records. | On baseline and after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With at Least 5% Weight Loss. | Based on medical records. | On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment |
| Average Absolute Weight Change | Based on medical records. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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).
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 anorexia.
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.
Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
Participation in other clinical trials within 3 months before enrolment in this trial.
Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | Russia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dietressa | Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. Dietressa: Oral administration. |
| FG001 | Placebo | Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks. Placebo: Oral administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral administration. |
|
| After 4, 8, 12, 16 and 20 weeks of treatment |
| Average Relative Weight Change | Based on medical records. | After 4, 8, 12, 16 and 20 weeks of treatment |
| Change in Waist Circumference, Waist Circumference/Hip Circumference. | Based on medical records. | After 4, 12 and 24 weeks of treatment |
| Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Based on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline | On baseline and after 4, 12, 24 weeks of treatment |
| First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty | Moscow | 119991 | Russia |
| 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 | Russia |
| Municipal Medical and Preventive institution "City Clinical Hospital No.10" | Nizhny Novgorod | 603011 | Russia |
| The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko" | Nizhny Novgorod | 603126 | Russia |
| 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 | Russia |
| St. Petersburg State Health Care institution "Municipal Hospital No.6" | Saint Petersburg | 191482 | Russia |
| St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center | Saint Petersburg | 192177 | Russia |
| The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency). | Saint Petersburg | 194291 | Russia |
| 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 | Russia |
| 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 | Russia |
| St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital" | Saint Petersburg | 197706 | Russia |
| St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center | Saint Petersburg | 198260 | Russia |
| 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 | Russia |
| 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 | Russia |
| The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center" | Voronezh | 394018 | Russia |
| The State Health Care institution of Yaroslavl Region the Clinical Hospital | Yaroslavl | 150062 | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dietressa | Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. Dietressa: Oral administration. |
| BG001 | Placebo | Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks. Placebo: Oral administration. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With at Least 5% Weight Loss. | Based on medical records. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Absolute Weight Change | Based on medical records. | Posted | Mean | Standard Deviation | kilogram | On baseline and after 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Average Relative Weight Change | Based on medical records. | ∆ between baseline and after 24 weeks | Posted | Mean | Standard Deviation | percentage of weight loss from baseline | On baseline and after 24 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With at Least 5% Weight Loss. | Based on medical records. | Posted | Count of Participants | Participants | On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Absolute Weight Change | Based on medical records. | Posted | Mean | Standard Deviation | kilogram | After 4, 8, 12, 16 and 20 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Relative Weight Change | Based on medical records. | Posted | Mean | Standard Deviation | percentage of weight loss from baseline | After 4, 8, 12, 16 and 20 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Based on medical records. | Posted | Mean | Standard Deviation | centimeter | After 4, 12 and 24 weeks of treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Based on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline | Posted | Mean | Standard Deviation | score on a scale | On baseline and after 4, 12, 24 weeks of treatment |
|
During the study - 24 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dietressa | Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. Dietressa: Oral administration. | 0 | 164 | 2 | 164 | 76 | 164 |
| EG001 | Placebo | Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks. Placebo: Oral administration. | 0 | 167 | 3 | 167 | 64 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Membranous nephropathy | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gangrenous appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Closed fracture of the right leg and right foot as a result of a fall |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Epigastric pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Heartburn |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Viral respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nail bed infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA | Systematic Assessment | Thrush |
|
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth pulpitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abnormal glucose tolerance test results | Investigations | MedDRA | Systematic Assessment |
| |
| Deviation from the ESR norm | Investigations | MedDRA | Systematic Assessment |
| |
| Increased blood pressure | Investigations | MedDRA | Systematic Assessment |
| |
| Increased ESR | Investigations | MedDRA | Systematic Assessment |
| |
| Increased ALT | Investigations | MedDRA | Systematic Assessment |
| |
| Increased AST | Investigations | MedDRA | Systematic Assessment |
| |
| Increased blood glucose | Investigations | MedDRA | Systematic Assessment |
| |
| Increased lymphocytes | Investigations | MedDRA | Systematic Assessment |
| |
| Increase in LDL cholesterol | Investigations | MedDRA | Systematic Assessment |
| |
| Increased monocytes | Investigations | MedDRA | Systematic Assessment |
| |
| Increased platelets | Investigations | MedDRA | Systematic Assessment |
| |
| Increased eosinophils | Investigations | MedDRA | Systematic Assessment |
| |
| Increased red blood cells | Investigations | MedDRA | Systematic Assessment |
| |
| Elevated LDL | Investigations | MedDRA | Systematic Assessment |
| |
| Elevated triglycerides | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased serum creatinine levels | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased platelets | Investigations | MedDRA | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA | Systematic Assessment |
| |
| Increased LDL to HDL ratio | Investigations | MedDRA | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Impaired fasting glycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Type II diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Anemia, unspecified | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Degenerative changes in the thoracic spine |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Lumbago |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Deforming osteoarthritis |
|
| Subchondral bone cyst | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cranial nerve neuritis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Increased activity | Nervous system disorders | MedDRA | Systematic Assessment | Psychomotor hyperactivity |
|
| Retinal dystrophy | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Chronic cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bartholin's gland cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Menstrual disorders | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment | Tibial vein thrombosis |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA | Systematic Assessment |
| |
| Increased body temperature | General disorders | MedDRA | Systematic Assessment |
| |
| Decreased activity | General disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depression, worsening | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Feeling of elation | Psychiatric disorders | MedDRA | Systematic Assessment | Euphoric mood |
|
| Increased anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Bruised toe | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director | MATERIA MEDICA HOLDING | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605985 | Dietressa |
Not provided
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|