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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding
ClinicalTrials.gov Identifier:
NCT01570829
First received: April 2, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose
  • 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 efficiency of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).

Condition Intervention Phase
Obesity
Drug: Dietressa
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficiency of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients

Resource links provided by NLM:


Further study details as provided by Materia Medica Holding:

Primary Outcome Measures:
  • Proportion of patients with body weight reduction by 5 percent and more after 24 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average body weight reduction (absolute and relative) after 24 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with body weight reduction by 5 percent and more after 4, 8, 12, 16 and 20 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Average body weight reduction (absolute and relative) after 4, 8, 12, 16 and 20 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in waist circumference, waist circumference to thigh circumference ratio after 4, 12 and 24 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dynamics of the quality of life according to the data of SF-36 questionnaire after 4, 12 and 24 weeks of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 332
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietressa (1 tablet 6 times daily) Drug: Dietressa
Safety and Efficiency of New Dosage Schedule
Placebo Comparator: Placebo (1 tablet 6 times daily) Drug: Placebo
Safety and Efficiency of New Dosage Schedule

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatient subjects with BMI 35,0-39,9 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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570829

Locations
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, 350063
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, 127018
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, 119991
Municipal Medical and Preventive institution "City Clinical Hospital No.10"
Nizhny Novgorod, Russian Federation, 603011
The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"
Nizhny Novgorod, Russian Federation, 603126
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, 344022
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, 197022
St. Petersburg State Health Care institution "Municipal Hospital No.6"
St. Petersburg, Russian Federation, 191482
St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center
St. Petersburg, Russian Federation, 192177
St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"
St. Petersburg, Russian Federation, 197706
St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center
St. Petersburg, Russian Federation, 198260
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, 194291
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, 197022
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, 450000
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, 400131
The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"
Voronezh, Russian Federation, 394018
The State Health Care institution of Yaroslavl Region the Clinical Hospital
Yaroslavl, Russian Federation, 150062
Sponsors and Collaborators
Materia Medica Holding
  More Information

No publications provided

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01570829     History of Changes
Other Study ID Numbers: MMH-DI-003
Study First Received: April 2, 2012
Last Updated: July 24, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

ClinicalTrials.gov processed this record on November 24, 2014