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

NCT01570829 | Completed Phase 3 Results

• 1 other identifier: MMH-DI-003
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 17

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Percentage of Patients With at Least 5% Weight Loss.

  On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment

• Average Absolute Weight Change

  After 4, 8, 12, 16 and 20 weeks of treatment

• Average Relative Weight Change

  After 4, 8, 12, 16 and 20 weeks of treatment

• Change in Waist Circumference, Waist Circumference/Hip Circumference.

  After 4, 12 and 24 weeks of treatment

• Dynamics of the Quality of Life According to the SF-36 Questionnaire.

  On baseline and after 4, 12, 24 weeks of treatment

Study Arms (2)

Dietressa

EXPERIMENTAL

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

Drug: Dietressa

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dietressa DRUG

Oral administration.

Dietressa

Placebo DRUG

Oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient subjects with BMI 35,0-39,9 kg/m2.
• Males or females aged from 18 to 65 years.
• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (17)

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

Location

First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty

Moscow, 119991, Russia

Location

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

Location

Municipal Medical and Preventive institution "City Clinical Hospital No.10"

Nizhny Novgorod, 603011, Russia

Location

The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"

Nizhny Novgorod, 603126, Russia

Location

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

Location

St. Petersburg State Health Care institution "Municipal Hospital No.6"

Saint Petersburg, 191482, Russia

Location

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

Saint Petersburg, 192177, Russia

Location

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

Location

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

Location

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

Location

St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"

Saint Petersburg, 197706, Russia

Location

St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center

Saint Petersburg, 198260, Russia

Location

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

Location

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

Location

The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"

Voronezh, 394018, Russia

Location

The State Health Care institution of Yaroslavl Region the Clinical Hospital

Yaroslavl, 150062, Russia

Location

MeSH Terms

Conditions

Obesity

Interventions

Dietressa

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 26, 2021
• Results First Posted: August 26, 2021

Record last verified: 2019-01

Locations

RU (17)