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Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

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ClinicalTrials.gov Identifier: NCT01786902
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : May 29, 2015
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Idiopathic Short Stature
Intervention Drug: DA-3002
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group
Hide Arm/Group Description

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment
Period Title: Overall Study
Started 36 34
Completed 32 31
Not Completed 4 3
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group Total
Hide Arm/Group Description

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment Total of all reporting groups
Overall Number of Baseline Participants 36 34 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 70 participants
6.75  (1.79) 7.17  (2.34) 6.96  (2.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 70 participants
Female
14
  38.9%
17
  50.0%
31
  44.3%
Male
22
  61.1%
17
  50.0%
39
  55.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 36 participants 34 participants 70 participants
36 34 70
1.Primary Outcome
Title Annualized Height Velocity(cm/Year) After 26 Weeks
Hide Description Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group
Hide Arm/Group Description:

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: cm/year
10.68  (1.95) 5.72  (1.72)
2.Secondary Outcome
Title Changes in Height Standard Deviation Score After 26 Weeks
Hide Description The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group
Hide Arm/Group Description:

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: ratio
0.63  (0.16) 0.06  (0.15)
3.Other Pre-specified Outcome
Title Changes in Anti-growth Hormone Antibody
Hide Description [Not Specified]
Time Frame baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group
Hide Arm/Group Description:

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment
Overall Number of Participants Analyzed 33 31
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.30  (0.35) 0.21  (0.54)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DA-3002 Treatment Group Non-treatment Control Group
Hide Arm/Group Description

1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)

DA-3002

Height be measured with no treatment
All-Cause Mortality
DA-3002 Treatment Group Non-treatment Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DA-3002 Treatment Group Non-treatment Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)   1/31 (3.23%) 
Infections and infestations     
Pharyngotonsillitis  1/36 (2.78%)  0/31 (0.00%) 
Surgical and medical procedures     
Strabismus correction  0/36 (0.00%)  1/31 (3.23%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DA-3002 Treatment Group Non-treatment Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   19/36 (52.78%)   14/31 (45.16%) 
Gastrointestinal disorders     
Enteritis  0/36 (0.00%)  1/31 (3.23%) 
Nausea  1/36 (2.78%)  0/31 (0.00%) 
Vomiting  0/36 (0.00%)  1/31 (3.23%) 
General disorders     
Pyrexia  5/36 (13.89%)  0/31 (0.00%) 
Immune system disorders     
Hypersensitivity  2/36 (5.56%)  0/31 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  8/36 (22.22%)  9/31 (29.03%) 
Injury, poisoning and procedural complications     
Laceration  0/36 (0.00%)  1/31 (3.23%) 
Nervous system disorders     
Dizziness  0/36 (0.00%)  1/31 (3.23%) 
Headache  1/36 (2.78%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1/36 (2.78%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1/36 (2.78%)  0/31 (0.00%) 
Surgical and medical procedures     
Strabismus correction  0/36 (0.00%)  1/31 (3.23%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hanwook Yoo
Organization: Asan Medical Center
Phone: 82-2-3010-3374
EMail: hwyoo@amc.seoul.kr
Layout table for additonal information
Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01786902     History of Changes
Other Study ID Numbers: DA3002_ISS_III
First Submitted: February 6, 2013
First Posted: February 8, 2013
Results First Submitted: November 20, 2014
Results First Posted: May 29, 2015
Last Update Posted: October 19, 2017