NCT02349243

Brief Summary

This is a randomized, controlled, double blind clinical trial. The purpose of this study is to investigate the weight loss efficacy of entacapone. In this study, participants are randomly divided into entacapone and placebo groups. The percentage change in body weight, the body mass index, waist circumstance, extent of fatty liver, quantity of visceral fat, serum insulin, serum triglyceride and the adverse effects are compared between the two groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 22, 2015

Last Update Submit

January 30, 2015

Conditions

Obesity

Keywords

obeseweight lossentacapone

Outcome Measures

Primary Outcomes (1)

  • Percentage change in bodyweight

    The final result will be assessed six months after intervention

    Monthly until the 6th month after the 1st intervention

Secondary Outcomes (7)

  • Changes in body mass index

    Monthly until the 6th month after the 1st intervention

  • Waist circumstance

    Monthly until the 6th month after the 1st intervention

  • Visceral adipose tissue

    Monthly until the 6th month after the 1st intervention

  • Serum adipokines

    Monthly until the 6th month after the 1st intervention

  • glucose tolerance index

    Monthly until the 6th month after the 1st intervention

  • +2 more secondary outcomes

Study Arms (2)

entacapone

EXPERIMENTAL

An approach of 200mg entacapone at a time and 4 times a day(0.5 hour after every breakfast, lunch and supper and at 0.5 hours before bedtime) is adopted. Every participant is required to record his/her diet, exercise, and drug intake condition in a standard record card which is provided by the researchers.

Drug: Entacapone

placebo

PLACEBO COMPARATOR

Except for taking the placebo rather than the entacapone, any intervention in the placebo group is the same with that in the entacapone group.

Drug: Placebo

Interventions

EntacaponeDRUG

200 mg entacapone, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months

Also known as: Comtan
entacapone
PlaceboDRUG

200 mg placebo, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months

Also known as: Sugar pills manufactured to mimic entacapone 200mg tablet
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) Obese which is defined as BMI ≥ 28kg/m2 ;
  • \) 18≤ age ≤60 years;
  • \) Permanent resident in Xi'an City, Shaanxi Province, China

You may not qualify if:

  • \) Unable to closely follow the diet and exercise regime;
  • \) Bodyweight changes beyond 4kg within 3 month before participating in this study;
  • \) Have a history of myocardial infarction or unstable angina within 6 month before participating in this study;
  • \) With endocrine, neurological, psychiatric or malignant diseases;
  • \) History of thyroid diseases;
  • \) Cardiac, hepatic and renal dysfunction;
  • \) Have a long history of using amcinonide;
  • \) With intestinal malabsorption;
  • \) With history of acute or chronic pancreatitis
  • \) With history of gastrointestinal surgery;
  • \) With history of bariatric surgery;
  • \) Using any other pharmacological drugs for weight loss;
  • \) Addicted to any drugs including alcohol;
  • \) Diabetes;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

entacaponeTablets

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Kaichun Wu, MD, PhD

    Xijing Hospital of Digestive Diseases, Xijing Hospital, Fourth Military Medical University

    STUDY CHAIR

Central Study Contacts

Kaichun Wu, PhD., MD.

CONTACT

86-29-84771502kaicwu@fmmu.edu.cn

Shiqi Wang, MD.

CONTACT

86-29-84771533wsqfmmu@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

CN(1)