Generic vs. Name-Brand Levothyroxine

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-03-31

Brief Summary

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This study compares two different brands of thyroxine (thyroid hormone). Currently, pharmacists may be substituting generic formulations of thyroid hormone without your doctor knowing about this. Although a small difference in thyroid function is not significant in most healthy children, adolescents and adults, in infants and toddlers even a small difference in thyroid function can have important harmful consequences on brain development. The purpose of the present study is to learn whether the difference between brands of thyroid hormone that are currently being substituted is sufficient to cause a difference in thyroid function.

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Detailed Description

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This study is an unblinded, randomized controlled cross-over study, which involves taking 2 different forms of levothyroxine sequentially over a 16 week period. Subjects will have a total of 3 visits over this time period. At the first visit, subjects are randomized to receive either generic (Sandoz) levothyroxine or Synthroid (Abbott) brand of levothyroxine. Blood is drawn for baseline thyroid function studies and other markers which are influenced by thyroid hormone at each visit. The second visit is the cross-over visit, and the final visit is a close-out visit, after which each subject will resume taking their previous formulation of levothyroxine.

Conditions

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Congenital Hypothyroidism Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brand name levothyroxine (Synthroid)

Dose previously demonstrated to normalize thyroid function given daily for 2 months

Group Type EXPERIMENTAL

Brand Name Levothyroxine (Synthroid)

Intervention Type DRUG

Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.

Generic formulation of Levothyroxine

Dosage previously determined to normalize thyroid function given daily for 2 months

Group Type ACTIVE_COMPARATOR

Generic formulation of Levothyroxine

Intervention Type DRUG

Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.

Interventions

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Brand Name Levothyroxine (Synthroid)

Randomized crossover study using 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott), then 8 weeks of the generic formulation of levothyroxine (manufactured by Sandoz). The dose of medication does not change throughout the duration of the study.

Intervention Type DRUG

Generic formulation of Levothyroxine

Randomized crossover study using 8 weeks of the generic formulation of levothyroxine (manufactured by Abbott, then 8 weeks of brand name levothyroxine (Synthroid, manufactured by Abbott). The dose of medication does not change throughout the duration of the study.

Intervention Type DRUG

Other Intervention Names

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Levothyroxine No other names

Eligibility Criteria

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Inclusion Criteria

* Age between 3 and 18 years
* Diagnosis of Congenital Hypothyroidism with initial TSH \> 100
* Ability to understand directions and follow all instructions