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

NCT01535014 | Completed Phase 3 Results

• 1 other identifier: MMH-DI-002
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 17

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• 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

• Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment

  assessed after 4,12 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

Study Arms (4)

Dietressa (2 tablets 3 times daily) for 24 weeks

EXPERIMENTAL

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.

Drug: Dietressa

Dietressa (1 tablet 6 times daily) for 24 weeks

EXPERIMENTAL

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.

Drug: Dietressa

Placebo (2 tablets 3 times daily)

PLACEBO COMPARATOR

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.

Drug: Placebo

Placebo (1 tablet 6 times daily)

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Dietressa DRUG

Comparison of different dosages (frequency) of drug

Dietressa (1 tablet 6 times daily) for 24 weeks; Dietressa (2 tablets 3 times daily) for 24 weeks

Placebo DRUG

Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)

Placebo (1 tablet 6 times daily); Placebo (2 tablets 3 times daily)

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 30,0-34,9 kg/m2.
• Male or female subjects aged 18 to 65 inclusive.
• 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, namely, 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 abepithymia.

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

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, 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: Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: February 14, 2012
• First Posted: February 17, 2012
• Study Start: December 12, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 28, 2018
• Results First Posted: October 18, 2018

Record last verified: 2018-11

Locations

RU (17)