Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Dietressa

• Registration Number: NCT01570829
• Lead Sponsor: Materia Medica Holding

Brief Summary

* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2).

* To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).

Detailed Description

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2019-01
• Results First Submitted: 2021-07-19
• Results First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Results First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

Inclusion Criteria

1. Outpatient subjects with BMI 35,0-39,9 kg/m2.
2. Males or females aged from 18 to 65 years.
3. Use of and compliance with contraception methods by patients of reproductive age, of both sexes.
4. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.

Exclusion Criteria

1. 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, for example, insulin, glucocorticosteroids, neuroleptics etc.).

2. Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment.

3. Participation in the lifestyle modification program within 6 months before enrollment.

4. 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.

5. Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy).

6. Type 1 and 2 diabetes mellitus.

7. Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis).

8. Circulatory failure, IIА degree and above.

9. Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease.

10. Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial.

11. Past history of bulimia / non-drug anorexia.

12. Past history of any bariatric surgeries.

13. Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit.

14. Surgeries scheduled within 6 months.

15. Allergy to/intolerance of any of the drug components used during treatment.

16. Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency.

17. Administration of drugs specified as "Prohibited concomitant therapy", within 6 months before enrollment.

18. Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial.

19. Drug and alcohol consumption (over 2 alc. units daily), mental diseases.

20. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Dietressa	Dietressa	Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.

Primary Outcome Measures

Name	Time	Method
Average Absolute Weight Change	On baseline and after 24 weeks	Based on medical records.
Percentage of Patients With at Least 5% Weight Loss.	24 weeks	Based on medical records.
Average Relative Weight Change	On baseline and after 24 weeks	Based on medical records.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With at Least 5% Weight Loss.	On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment	Based on medical records.
Average Absolute Weight Change	After 4, 8, 12, 16 and 20 weeks of treatment	Based on medical records.
Change in Waist Circumference, Waist Circumference/Hip Circumference.	After 4, 12 and 24 weeks of treatment	Based on medical records.
Dynamics of the Quality of Life According to the SF-36 Questionnaire.	On baseline and after 4, 12, 24 weeks of treatment	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
Average Relative Weight Change	After 4, 8, 12, 16 and 20 weeks of treatment	Based on medical records.

Trial Locations

Locations (17)

The State Budget Health Care institution of Moscow the City Clinical Hospital No. 11 of the Administration of Health Care of Moscow City; 🇷🇺 Moscow, Russian Federation

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 na Donu, Russian Federation

St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"; 🇷🇺 St. Petersburg, Russian Federation

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; 🇷🇺 St.Petersburg, Russian Federation

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, Russian Federation

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, Russian Federation

The State Health Care institution of Yaroslavl Region the Clinical Hospital; 🇷🇺 Yaroslavl, Russian Federation

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, Russian Federation

First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty; 🇷🇺 Moscow, Russian Federation

Municipal Medical and Preventive institution "City Clinical Hospital No.10"; 🇷🇺 Nizhny Novgorod, Russian Federation

The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"; 🇷🇺 Nizhny Novgorod, Russian Federation

St. Petersburg State Health Care institution "Municipal Hospital No.6"; 🇷🇺 St. Petersburg, Russian Federation

The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency).; 🇷🇺 St. Petersburg, Russian Federation

St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center; 🇷🇺 St. Petersburg, Russian Federation

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; 🇷🇺 St. Petersburg, Russian Federation

St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center; 🇷🇺 St. Petersburg, Russian Federation

The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"; 🇷🇺 Voronezh, Russian Federation