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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535014
• Other study ID #: MMH-DI-002
• Status: Completed
• Phase: Phase 3
• Start date: December 12, 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2018
• Source: Materia Medica Holding
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, II? 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.

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Dietressa
Comparison of different dosages (frequency) of drug
• Placebo
Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)

Locations

Country	Name	City	State
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	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 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	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	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 "Consultative and Diagnostic Center No. 85", Diabetes Center	St. Petersburg
Russian Federation	St. Petersburg State Health Care institution "Municipal Hospital No.6"	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	St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"	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	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	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 "Voronezh Regional Clinical Consultative & Diagnostic Center"	Voronezh
Russian Federation	The State Health Care institution of Yaroslavl Region the Clinical Hospital	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Materia Medica Holding

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Average Body Weight Change After 24 Weeks of Treatment		assessed after 24 weeks of treatment
Primary	Average Relative Change in Body Weight After 24 Weeks of Treatment		assessed after 24 weeks of treatment
Secondary	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
Secondary	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
Secondary	Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment		assessed after 4,12 and 24 weeks of treatment
Secondary	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.	baseline, 4, 12 and 24 weeks