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

Phase 3

Completed

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

• Registration Number: NCT01535014
• Lead Sponsor: Materia Medica Holding

Brief 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.

* 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 Timeline

• Study Start: 2011-12-12
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2017-10-30
• Results First Submitted QC: 2018-10-17
• Results First Posted: 2018-10-18
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-01
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 493

Inclusion Criteria

1. Outpatient subjects with BMI 30,0-34,9 kg/m2.
2. Male or female subjects aged 18 to 65 inclusive.
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, namely, 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 abepithymia.

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. Legal incapacity or limited legal capacity.

20. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.

21. Participation in other clinical trials within 3 months before enrolment in this trial.

22. 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.

23. 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
Dietressa (2 tablets 3 times daily) for 24 weeks	Dietressa	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.
Dietressa (1 tablet 6 times daily) for 24 weeks	Dietressa	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.
Placebo (2 tablets 3 times daily)	Placebo	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.
Placebo (1 tablet 6 times daily)	Placebo	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment	assessed after 4,12 and 24 weeks of treatment
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment	assessed after 4, 8, 12, 16, 20 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	baseline, 4, 12 and 24 weeks	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.

Trial Locations

Locations (17)

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

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, Russian Federation

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 Kuban State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Clinical Pharmacology; 🇷🇺 Krasnodar, Russian Federation

Municipal Medical and Preventive institution "City Clinical Hospital No.10"; 🇷🇺 Nizhny Novgorod, 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 "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 "Volgograd State Medical University" of Ministry of Health Care and Social Development of the Russian Federation; 🇷🇺 Volgograd, 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 "Municipal Hospital No.6"; 🇷🇺 St. Petersburg, 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.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 "Saint Venerable Martyr Elizaveta Municipal Hospital"; 🇷🇺 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 of Yaroslavl Region the Clinical Hospital; 🇷🇺 Yaroslavl, Russian Federation

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