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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

April 2, 2012
July 24, 2013
December 2011
June 2013   (final data collection date for primary outcome measure)
  • 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 ]
Percentage 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 ]
Complete list of historical versions of study NCT01570829 on ClinicalTrials.gov Archive Site
  • 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 ]
Percentage 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 ]
Not Provided
Not Provided
 
Clinical Trial of Safety and Efficiency of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients
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
  • 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).

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: Dietressa
    Safety and Efficiency of New Dosage Schedule
  • Drug: Placebo
    Safety and Efficiency of New Dosage Schedule
  • Experimental: Dietressa (1 tablet 6 times daily)
    Intervention: Drug: Dietressa
  • Placebo Comparator: Placebo (1 tablet 6 times daily)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
June 2013
June 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01570829
MMH-DI-003
No
Materia Medica Holding
Materia Medica Holding
Not Provided
Not Provided
Materia Medica Holding
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP