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Trial record 1 of 1 for:    LE-9999-401-BE
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Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01916304
First received: August 1, 2013
Last updated: June 22, 2015
Last verified: June 2015
  Purpose
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

Condition Intervention Phase
Hypothyroidism Drug: Levothyroxine sodium new formulation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants That Do Not Need a Change of Dose [ Time Frame: 2 months (± 2 weeks) after switch to sodium formulation. ]
    Dose change was determined by physician according to their clinical judgement.


Secondary Outcome Measures:
  • Magnitude of the Change in Daily Dose Needed [ Time Frame: 2 months (± 2 weeks) after switch to sodium formulation. ]
    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.

  • Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L [ Time Frame: Month 4 (± 4 weeks) after inclusion into study. ]
    Blood samples were collected and samples were analyzed according to the local Quality System.

  • Absolute Serum Thyroid Stimulating Hormone Values [ Time Frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. ]
    Blood samples were collected and samples were analyzed according to the local Quality System.

  • Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone [ Time Frame: Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study. ]
    Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.


Enrollment: 101
Study Start Date: July 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Levothyroxine sodium new formulation
Levothyroxine tablets

Detailed Description:

The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.

The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.

The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).

All participants will be asked to take a daily dose at the same time each day throughout the study.

This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. (Near) total thyroidectomised patients.
  2. Aged 18 years and older.
  3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
  4. Written informed consent given.
  5. Able and willing to comply with protocol requirements and to complete the study.

Exclusion Criteria:

  1. History of Graves' disease or positive TSH-receptor antibodies.
  2. History of thyroid cancer requiring TSH suppression.
  3. Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
  4. Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
  5. Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
  6. Participation in another trial in the past 6 weeks.
  7. Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916304

Locations
Belgium
Leuven, Belgium
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Responsible Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01916304     History of Changes
Other Study ID Numbers: LE-9999-401-BE
2012-005732-28 ( EudraCT Number )
U1111-1145-3526 ( Registry Identifier: UTN (WHO) )
Study First Received: August 1, 2013
Results First Received: June 22, 2015
Last Updated: June 22, 2015

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 22, 2017