Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01184560
First received: August 16, 2010
Last updated: August 18, 2010
Last verified: October 2009

August 16, 2010
August 18, 2010
February 2010
July 2010   (final data collection date for primary outcome measure)
  • Weight [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    Weight
  • BMI(Body Mass Index) [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    BMI(Body Mass Index)
  • waist circumference [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    waist circumference
  • blood pressure [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    blood pressure
  • fat mass [ Time Frame: with in 18weeks ]
    fat mass
  • visceral fat mass improvement [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    visceral fat mass improvement
Same as current
Complete list of historical versions of study NCT01184560 on ClinicalTrials.gov Archive Site
  • Lipid profile [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    Total cholesterol, HDL-C(high-density lipoprotein-cholesterol), LDL-C(low-density lipoprotein-cholesterol), Triglyceride improvement
  • Adipokines improvement [ Time Frame: with in 18weeks ] [ Designated as safety issue: No ]
    Serum insulin, adiponectin, leptin, ghrelin, serum ostecalcin, urine deoxypyridinolin
Same as current
Not Provided
Not Provided
 
Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Study to Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze.

  • Study phase: Investigator-initiated clinical study (Pilot study)
  • Method of blinding: Double-blind
  • Control: Placebo-controlled
  • Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1)
  • Studied disease: Obesity
  • Study population: Subjects eligible for inclusion/exclusion criteria
  • Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)

After the screening period, patients eligible for inclusion/exclusion criteria would administer Sibutramine placebo and Orlistat placebo during 2 weeks of the run-in period, Subsequently, subjects are randomized to 2 groups of the Sibutramine monotherapy group and the Orlistat and Sibutramine combination group. Sibutramine monotherapy group would receive Sibutramine 10mg once daily and Orlistat placebo three times daily for 12 weeks; the Orlistat and Sibutramine combination group would receive Sibutramine 10mg once daily and Orlistat 120mg three times daily for 12 weeks. After completing the dosing period, the occurrence of adverse events would be checked for 4 weeks and the study would be completed.

Body weight, abdominal CT(Computed Tomography)(visceral fat examination), body fat analysis, etc. would be measured before the study initiation and after 14 weeks of treatment, and comparatively analyzed. A two sample t-test is conducted for the inter-group comparison and a paired t-rest is conducted for the comparison between baseline and after 14 weeks after the study initiation.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: Sibutramine

    ○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.

    Treatment period: The total dosing period is 12 weeks.

    • Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
    • Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily
  • Drug: Orlistat

    ○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.

    Treatment period: The total dosing period is 12 weeks.

    • Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
    • Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily
  • Experimental: Sibutramine + Orlistat
    A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence
    Interventions:
    • Drug: Sibutramine
    • Drug: Orlistat
  • Placebo Comparator: Sibutramine + Orlistat(Placebo)
    1. Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat.
    2. Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence.
    Interventions:
    • Drug: Sibutramine
    • Drug: Orlistat

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
July 2010
July 2010   (final data collection date for primary outcome measure)

MAOInclusion Criteria:

  1. A patient who gave one's voluntary written consent to participate in this clinical study
  2. Aged ≥ 18 and < 50 years old
  3. An obese patient with a body mass index (BMI) ≥ 27 kg/m2
  4. In case of a women, premenopausal woman

Exclusion Criteria:

  1. A patient with the weight change ≥ 5% over the past 3 months
  2. A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
  3. A patient with an active acute or chronic disease at the participation of the study
  4. A patient with the malignancy history within the past 5 years
  5. A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
  6. A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
  7. A patient falling under the followings from screening test results Hemoglobin < 10g/L or platelets < 100* 103/μL Total bilirubin > 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) > 120 IU/L Serum creatinine > 1.4mg/dL Serum uric acid > 10mg/dL Thyroid stimulating hormone < 0.1μIU/mL or > 6.5 μIU/mL
  8. A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
  9. A pregnant women or breastfeeding mother
  10. A patient participating in another clinical study other than this study
  11. Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
  12. A person who participated in other clinical study within the past 3 months
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01184560
HM-OPS
Yes
Kyoungkon Kim/Principal Investigator, GachonGill Medical Center
Gachon University Gil Medical Center
Not Provided
Principal Investigator: Kim Kyoungkon GachonGill Medical Center
Gachon University Gil Medical Center
October 2009

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