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Trial record 6 of 11 for:    Congenital Hypothyroidism

Generic vs. Name-Brand Levothyroxine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403390
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jeremi Carswell, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Congenital Hypothyroidism
Hypothyroidism
Interventions Drug: Brand Name Levothyroxine (Synthroid)
Drug: Generic formulation of Levothyroxine
Enrollment 34
Recruitment Details Subjects were recruited through flyers in the endocrine clinic and letters with opt-out cards to contact. Recruitment started November 2006 and completed ended March 2010.
Pre-assignment Details Subjects' ages had to be between 3-18 years and had a diagnosis of hypothyroidism, either congenital or acquired with an initial TSH of >100 uIU/mL.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks Generic levothyroxine for 8 weeks then branded Synthroid for 8 weeks
Period Title: Overall Study
Started 16 18
Completed 13 18
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             1             0
samples lost             1             0
non-compliant             1             0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks Generic levothyroxine 8 weeks, then branded Synthroid 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 13 18 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 18 participants 31 participants
<=18 years
13
 100.0%
18
 100.0%
31
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 18 participants 31 participants
10  (1.2) 10  (1.0) 10  (1.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 18 participants 31 participants
Female
9
  69.2%
15
  83.3%
24
  77.4%
Male
4
  30.8%
3
  16.7%
7
  22.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 18 participants 31 participants
13 18 31
1.Primary Outcome
Title Thyroid Stimulating Hormone as Primary Endpoint Measured at Initiation of Study, After 8 Weeks of One Drug, and Then 8 Weeks After the Second Drug.
Hide Description [Not Specified]
Time Frame 3 points over 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks
Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks
Overall Number of Participants Analyzed 13 18
Mean (Standard Error)
Unit of Measure: uIU/mL
Baseline 2.455  (1.532) 2.131  (1.322)
After first drug 0.788  (0.631) 3.053  (1.233)
After second drug 3.112  (4.983) 1.217  (2.832)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description Crossover; Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks Crossover; Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks, then generic
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/18 (0.00%) 
Proof of principle study; small sample. Results may not be applicable to all populations.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeremi Carswell, MD
Organization: Children's Hospital Boston
Phone: 617-355-7476
EMail: Jeremi.Carswell@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Jeremi Carswell, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT00403390     History of Changes
Other Study ID Numbers: 05-11-146
First Submitted: November 21, 2006
First Posted: November 23, 2006
Results First Submitted: January 20, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018