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出境医 / 临床实验 / Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat (SMF)

Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat (SMF)

Study Description
Brief Summary:
Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Condition or disease Intervention/treatment Phase
Submental Fat Drug: Normal saline Drug: DWJ211 Phase 3

Detailed Description:
DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : June 25, 2020
Estimated Study Completion Date : June 25, 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo group
Inject the Drug into submental fat via subcutaneous
 Drug: Normal saline
Inject the Drug into submental fat via subcutaneous
Experimental: DWJ211 group
Inject the Drug into submental fat via subcutaneous
 Drug: DWJ211
Inject the Drug into submental fat via subcutaneous
Outcome Measures
Primary Outcome Measures :
  1. PA-SMFRS, SA-SMFRS [ Time Frame: 12 week after last treatment ]
    Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
  • Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
  • Less than 35kg/m2 in body mass index on Visit1.
  • Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.

Exclusion Criteria:

  • History of any intervention to treat SMF
  • History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
  • Evidence of any cause of enlargement in the submental area.
  • History or current symptoms of dysphagia.
Contacts and Locations

Contacts
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Contact: MIJUNG SONG +82-2-550-8368 mjsong257@daewoong.co.kr

Locations
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Korea, Republic of
Chung-ang university hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE May 7, 2019
Estimated Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		PA-SMFRS, SA-SMFRS [ Time Frame: 12 week after last treatment ]
Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 1-grade response : PA-SMFRS, SA-SMFRS [ Time Frame: 12 week after last treatment ]
    Proportion of subject who simultaneously have at least a 1 grade improvement from baseline on the PA-SMFRS, SA-SMFRS at 12weeks after the last treatment
  • 2-grade response : PA-SMFRS, SA-SMFRS [ Time Frame: 12 week after last treatment ]
    Proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS, SA-SMFRS at 12weeks after the last treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 1-grade, 2-grade response : PA-SMFRS, SA-SMFRS [ Time Frame: 4, 12 week after last treatment ]
    Proportion of subject who simultaneously have at least a 1 grade, 2 grade improvement from baseline on the PA-SMFRS, SA-SMFRS at 12weeks after the last treatment
  • obtained 5 score : SSS [ Time Frame: 4, 12 week after last treatment ]
    proportion of subjects who have more than 5 score on the SSS(somewhat satisfied)
  • improvement: SA-SMFIS [ Time Frame: 4, 12 week after last treatment ]
    improvement in the Subject reported submental fat impact scale overall score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Official Title  ICMJE A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Brief Summary Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
Detailed Description DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Submental Fat
Intervention  ICMJE
  • Drug: Normal saline
    Inject the Drug into submental fat via subcutaneous
  • Drug: DWJ211
    Inject the Drug into submental fat via subcutaneous
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Inject the Drug into submental fat via subcutaneous
    Intervention: Drug: Normal saline
  • Experimental: DWJ211 group
    Inject the Drug into submental fat via subcutaneous
    Intervention: Drug: DWJ211
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 25, 2020
Estimated Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
  • Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
  • Less than 35kg/m2 in body mass index on Visit1.
  • Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.

Exclusion Criteria:

  • History of any intervention to treat SMF
  • History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
  • Evidence of any cause of enlargement in the submental area.
  • History or current symptoms of dysphagia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946592
Other Study ID Numbers  ICMJE DW_DWJ211301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daewoong Pharmaceutical Co. LTD.
Study Sponsor  ICMJE Daewoong Pharmaceutical Co. LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewoong Pharmaceutical Co. LTD.
Verification Date May 2019

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

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