Trial Outcomes & Findings for Generic vs. Name-Brand Levothyroxine (NCT NCT00403390)

NCT ID: NCT00403390

Last Updated: 2018-02-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 3 points over 16 weeks
• Results posted on: 2018-02-23

Participant Flow

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.

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.

Participant milestones

Measure	Group 1 Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks	Group 2 Generic levothyroxine for 8 weeks then branded Synthroid for 8 weeks
Overall Study STARTED	16	18
Overall Study COMPLETED	13	18
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Group 1 Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks	Group 2 Generic levothyroxine for 8 weeks then branded Synthroid for 8 weeks
Overall Study Withdrawal by Subject	1	0
Overall Study samples lost	1	0
Overall Study non-compliant	1	0

Baseline Characteristics

Generic vs. Name-Brand Levothyroxine

Baseline characteristics by cohort

Measure	Group 1 n=13 Participants Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks	Group 2 n=18 Participants Generic levothyroxine 8 weeks, then branded Synthroid 8 weeks	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10 years STANDARD_DEVIATION 1.2 • n=5 Participants	10 years STANDARD_DEVIATION 1.0 • n=7 Participants	10 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	18 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 points over 16 weeks

Outcome measures

Measure	Group 1 n=13 Participants Branded Synthroid 8 weeks, then generic levothyroxine 8 weeks	Group 2 n=18 Participants Generic levothyroxine 8 weeks, then Branded Synthroid 8 weeks
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. Baseline	2.455 uIU/mL Standard Error 1.532	2.131 uIU/mL Standard Error 1.322
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. After first drug	0.788 uIU/mL Standard Error 0.631	3.053 uIU/mL Standard Error 1.233
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. After second drug	3.112 uIU/mL Standard Error 4.983	1.217 uIU/mL Standard Error 2.832

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremi Carswell, MD

Children's Hospital Boston

Phone: 617-355-7476

Email: Jeremi.Carswell@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place