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Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity

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

NCT05821543•Promomed, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
•2. Men and women aged 18 to 65 years inclusive at the time of signing the Informed Consent Form in PIL.
•3. The presence of alimentary obesity.
•4. BMI \>30 kg/m2.
•5. Failure of non-pharmacological treatment at the time of screening (weight loss \<5% within 3 months of treatment).
•6. Patient consent to change in diet, eating behavior, and increased physical activity, and adherence to the investigator's recommendations throughout participation in the study
•7. 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

•1. Hypersensitivity to the components of the study drug/comparator drug
•2. Secondary (symptomatic) obesity.
•3. Diabetes mellitus type I or II in history and/or at the time of screening.
•4. Use of a low-calorie (\<1600 kcal/day) diet for 3 months prior to screening.
•5. Patients who previously received drugs based on sibutramine.
•6. The use of drugs, herbal remedies or dietary supplements for the treatment of obesity less than 3 months prior to screening.
•7. Use of systemic glucocorticosteroids for less than 3 months prior to screening.
•8. Plan to change current smoking status during the study or quit smoking less than 3 months prior to screening.
•9. The need for surgical treatment of obesity during the study or the history of this treatment.
•10. Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
+34 more criteria

Locations (8)

Ivanovo Clinical Hospital named after Kuvaev

Ivanovo, Russia

Kirov State Medical University

Kirov, Russia

Pirogov Russian National Research Medical University

Moscow, Russia

"Rostov State Medical University" of the Ministry of Health of the Russian Federation

Rostov-on-Don, Russia

"Clinical hospital "RZD-Medicine" of the city of St. Petersburg"

Saint Petersburg, Russia

Avrora Limited Liability Company Principal

Saint Petersburg, Russia

Limited Liability Company "Medica"

Saint Petersburg, Russia

OrKli Hospital Limited Liability Company

Saint Petersburg, Russia

Key Dates

Start Date

July 3, 2020

Primary Completion Date

May 21, 2021

Completion Date

May 21, 2021

Last Updated

April 24, 2023

Enrollment

240

ACTUAL participants

Conditions

Obesity

Interventions

metformin+sibutramine

DRUG

sibutramine+ microcrystalline cellulose

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity

Inclusion Criteria

Exclusion Criteria

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