An Open-label, Multicentre, Randomized Comparative Study to Evaluate the Efficacy and Safety of Using the Sibutramin-containing Drugs Reduxin® Forte and Reduxin® in Patients With Alimentary Obesity
Overview
- Phase
- Phase 4
- Intervention
- metformin+sibutramine
- Conditions
- Obesity
- Sponsor
- Promomed, LLC
- Enrollment
- 240
- Locations
- 8
- Primary Endpoint
- The rate of achieving >5% weight loss
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St. Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.
Detailed Description
Male and female patients (240 people) inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
- •Men and women aged 18 to 65 years inclusive at the time of signing the Informed Consent Form in PIL.
- •The presence of alimentary obesity.
- •BMI \>30 kg/m
- •Failure of non-pharmacological treatment at the time of screening (weight loss \<5% within 3 months of treatment).
- •Patient consent to change in diet, eating behavior, and increased physical activity, and adherence to the investigator's recommendations throughout participation in the study
- •Patient's consent to use reliable contraceptive methods through out the study and for 3 weeks after the end of the study. The following people could take part in the study:
- •women who have a negative pregnancy test and use the following contraceptive methods: a barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or a double barrier method of contraception (condom or occlusive cap). The use of estrogen-containing contraceptives was allowed provided that the drug was used in one dosing regimen for at least 3 months prior to study entry and it was planned to use it at the same dosing regimen throughout the study participation. Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause for more than 1 year) or
- •men with preserved reproductive function using barrier contraceptives, as well as men with infertility or a history of vasectomy
Exclusion Criteria
- •Hypersensitivity to the components of the study drug/comparator drug
- •Secondary (symptomatic) obesity.
- •Diabetes mellitus type I or II in history and/or at the time of screening.
- •Use of a low-calorie (\<1600 kcal/day) diet for 3 months prior to screening.
- •Patients who previously received drugs based on sibutramine.
- •The use of drugs, herbal remedies or dietary supplements for the treatment of obesity less than 3 months prior to screening.
- •Use of systemic glucocorticosteroids for less than 3 months prior to screening.
- •Plan to change current smoking status during the study or quit smoking less than 3 months prior to screening.
- •The need for surgical treatment of obesity during the study or the history of this treatment.
- •Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
Arms & Interventions
Reduxin Forte
Arm 1 (n=120) received metformin+sibutramine p. o., 1 tablet (850 mg + 10 mg) once per day. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
Intervention: metformin+sibutramine
Reduxin
Arm 2 (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
Intervention: sibutramine+ microcrystalline cellulose
Outcomes
Primary Outcomes
The rate of achieving >5% weight loss
Time Frame: From baseline to Visit 13 (study completion, 180 days)
The proportion of patients who had achieved more than 5% weight loss
Secondary Outcomes
- The dynamic of hip width(From baseline to Visit 13 (study completion, 180 days))
- The dynamic of waist / hip measurements(From baseline to Visit 13 (study completion, 180 days))
- Dynamics of lipid profile indicators (TG, total cholesterol, LDL-cholesterol, HDL-cholesterol)(From baseline to Visit 13 (study completion, 180 days))
- The dynamic of quality of life(From baseline to Visit 13 (study completion, 180 days))
- The dynamic of waist measurement(From baseline to Visit 13 (study completion, 180 days))
- The dynamic of BMI(From baseline to Visit 13 (study completion, 180 days))
- The magnitude of the change in body weight(From baseline to Visit 13 (study completion, 180 days))
- The dynamic of body weight(From baseline to Visit 13 (study completion, 180 days))
- The frequency of patients who required an increase in the dose of the study / reference drug(From baseline to Visit 3 (30±1 days))
- The change in Body Mass Index (BMI)(From baseline to Visit 13 (study completion, 180 days))