Trial Outcomes & Findings for Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation (NCT NCT01916304)
NCT ID: NCT01916304
Last Updated: 2015-07-20
Results Overview
Dose change was determined by physician according to their clinical judgement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
2 months (± 2 weeks) after switch to sodium formulation.
Results posted on
2015-07-20
Participant Flow
Participants took part in the study at 8 investigative sites in Belgium from 02 July 2013 (first patient screened) to 23 June 2014.
Participants with a diagnosis of Primary Hypothyroidism were switched from treatment with L-Thyroxine Christiaens® to treatment with new levothyroxine sodium 25-225 μg.
Participant milestones
| Measure |
Levothyroxine Sodium New Formulation
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Overall Study
STARTED
|
101
|
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Overall Study
Safety Set
|
101
|
|
Overall Study
Intent-to-Treat Set
|
84
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Levothyroxine Sodium New Formulation
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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Overall Study
Screening failure
|
17
|
Baseline Characteristics
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Baseline characteristics by cohort
| Measure |
Levothyroxine Sodium New Formulation
n=101 Participants
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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Age, Continuous
|
54.1 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
|
Age, Customized
<65 years
|
78 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
23 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
101 participants
n=5 Participants
|
|
Weight
|
76.9 kg
STANDARD_DEVIATION 18.05 • n=5 Participants
|
|
Height
|
168.4 cm
STANDARD_DEVIATION 8.57 • n=5 Participants
|
|
Investigator Reported Body Mass Index (BMI)
|
27.2 kg/m^2
STANDARD_DEVIATION 5.98 • n=5 Participants
|
|
Calculated BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 6.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 months (± 2 weeks) after switch to sodium formulation.Population: Participants from the intent-to-treat population, with data available for analysis.
Dose change was determined by physician according to their clinical judgement.
Outcome measures
| Measure |
Levothyroxine Sodium New Formulation
n=82 Participants
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Percentage of Participants That Do Not Need a Change of Dose
|
32.9 percentage of participants
Interval 23.7 to 43.7
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SECONDARY outcome
Timeframe: 2 months (± 2 weeks) after switch to sodium formulation.Population: Participants from the intent-to-treat population, with data available for analysis.
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.
Outcome measures
| Measure |
Levothyroxine Sodium New Formulation
n=82 Participants
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Magnitude of the Change in Daily Dose Needed
-25 μg change
|
19.51 percentage of participants
|
|
Magnitude of the Change in Daily Dose Needed
-12.5 μg change
|
42.68 percentage of participants
|
|
Magnitude of the Change in Daily Dose Needed
-6.25 μg change
|
1.22 percentage of participants
|
|
Magnitude of the Change in Daily Dose Needed
-5.35 μg change
|
1.22 percentage of participants
|
|
Magnitude of the Change in Daily Dose Needed
0 μg change
|
32.93 percentage of participants
|
|
Magnitude of the Change in Daily Dose Needed
+12.5 μg change
|
2.44 percentage of participants
|
SECONDARY outcome
Timeframe: Month 4 (± 4 weeks) after inclusion into study.Population: Participants from the intent-to-treat population, with data available for analysis.
Blood samples were collected and samples were analyzed according to the local Quality System.
Outcome measures
| Measure |
Levothyroxine Sodium New Formulation
n=82 Participants
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L
|
57.3 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.Population: Participants from the intent-to-treat population, with data available for analysis.
Blood samples were collected and samples were analyzed according to the local Quality System.
Outcome measures
| Measure |
Levothyroxine Sodium New Formulation
n=84 Participants
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Absolute Serum Thyroid Stimulating Hormone Values
Baseline
|
1.1 mIU/mL
Inter-Quartile Range 0.59 • Interval 0.7 to 1.6
|
|
Absolute Serum Thyroid Stimulating Hormone Values
Month 2 (n=83)
|
0.3 mIU/mL
Inter-Quartile Range 1.69 • Interval 0.1 to 0.6
|
|
Absolute Serum Thyroid Stimulating Hormone Values
Month 4 (n=82)
|
0.6 mIU/mL
Inter-Quartile Range 1.09 • Interval 0.2 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.Population: Participants from the intent-to-treat population, with data available for analysis.
Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Levothyroxine Sodium New Formulation
n=83 Participants
Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
|
|---|---|
|
Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
Month 2
|
-74.5 percent change
Inter-Quartile Range 192.14 • Interval -89.5 to -50.6
|
|
Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone
Month 4 (n=82)
|
-54.0 percent change
Inter-Quartile Range 173.36 • Interval -75.1 to -15.5
|
Adverse Events
Levothyroxine Sodium New Formulation
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levothyroxine Sodium New Formulation
n=101 participants at risk
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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Cardiac disorders
Cardiac failure
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Investigations
Catheterisation cardiac
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Surgical and medical procedures
Hysterectomy
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Surgical and medical procedures
Mastectomy
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Surgical and medical procedures
Salivary gland resection
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
|
Vascular disorders
Haemorrhage
|
0.99%
1/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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.
|
Other adverse events
| Measure |
Levothyroxine Sodium New Formulation
n=101 participants at risk
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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Infections and infestations
Nasopharyngitis
|
6.9%
7/101 • 5 months from inclusion (all patients) or up to recovery/final status is known for AE's.
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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER