|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00403390 |
|
Date of registration:
|
21/11/2006 |
|
Primary sponsor: |
|
|
Public title:
|
Generic vs. Name-Brand Levothyroxine
|
|
Scientific title:
|
Generic vs. Name-Brand Levothyroxine: Assessment of Bioequivalence Using TSH as a Marker in Children With Permanent Hypothyroidism |
|
Date of first enrolment:
|
November 2006 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00403390 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Rosalind S Brown, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Children's Hospital Boston |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age between 3 and 18 years
- Diagnosis of Congenital Hypothyroidism with initial TSH > 100
- Ability to understand directions and follow all instructions
Exclusion Criteria:
- Not on any drug interfering with absorption of levothyroxine
Age minimum:
3 Years
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Congenital Hypothyroidism
|
|
Hypothyroidism
|
|
Intervention(s)
|
|
Drug: Levothyroxine versus Levothyroxine
|
|
Primary Outcome(s)
|
|
Thyroid Stimulating Hormone Measure
[Time Frame: 3 points over 16 weeks]
|
|
Secondary ID(s)
|
|
05-11-146
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|