Clinical Trial Results:
A multicentre, open-label switch study to investigate the necessity of dose adjustment after switching from L-Thyroxine Christiaens® to the new levothyroxine sodium test formulation in (near) total thyroidectomised patients.
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Summary
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EudraCT number |
2012-005732-28 |
Trial protocol |
BE |
Global end of trial date |
23 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Mar 2016
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First version publication date |
08 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LE-9999-401-BE
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01916304 | ||
WHO universal trial number (UTN) |
U1111-1145-3526 | ||
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Sponsors
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Sponsor organisation name |
Takeda
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Sponsor organisation address |
One Takeda Parkway, Deerfield, IL, United States, 60015
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Public contact |
Medical Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.com
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Scientific contact |
Medical Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Dec 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new formulation.
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Protection of trial subjects |
All participants were required to read and sign an informed consent form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jul 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 101
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Worldwide total number of subjects |
101
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EEA total number of subjects |
101
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
78
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 to 23 June 2014. | ||||||||||||||
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Pre-assignment
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Screening details |
Participants with a diagnosis of Primary Hypothyroidism were switched from treatment with L-Thyroxine Christiaens® to treatment with new levothyroxine sodium 25-225 μg. | ||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Levothyroxine sodium new formulation | ||||||||||||||
Arm description |
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
levothyroxine sodium new formulation
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
25 to 225 μg once daily (dose dependent on TSH level) for 12 to 20 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Levothyroxine sodium new formulation
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Reporting group description |
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Levothyroxine sodium new formulation
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Reporting group description |
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. | ||
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End point title |
Percentage of Participants that Do Not Need a Change of Dose [1] | ||||||||
End point description |
Dose change was determined by physician according to their clinical judgement.
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End point type |
Primary
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End point timeframe |
2 months (± 2 weeks) after switch to sodium formulation.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis is not reported for this outcome measure. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Magnitude of the Change in Daily Dose Needed | ||||||||||||||||||||
End point description |
Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.
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End point type |
Secondary
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End point timeframe |
2 months (± 2 weeks) after switch to sodium formulation.
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Relative Percent Change from Baseline in Serum Thyroid Stimulating Hormone | ||||||||||||
End point description |
Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants that Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L | ||||||||
End point description |
Blood samples were collected and samples were analyzed according to the local Quality System.
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End point type |
Secondary
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End point timeframe |
Month 4 (± 4 weeks) after inclusion into study.
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| No statistical analyses for this end point | |||||||||
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End point title |
Absolute Serum Thyroid Stimulating Hormone Values | ||||||||||||||
End point description |
Blood samples were collected and samples were analyzed according to the local Quality System.
Participants from the intent-to-treat population, all enrolled participants, with data available for analysis.
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End point type |
Secondary
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End point timeframe |
Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Study inclusion to recovery or final status is known of adverse drug reactions (ADRs) [up to 5 months]
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Adverse event reporting additional description |
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Levothyroxine sodium new formulation
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Reporting group description |
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
