Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation

NCT01916304 | Completed Phase 2 Results

• 3 other identifiers: LE-9999-401-BE2012-005732-28U1111-1145-3526
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

Conditions

Hypothyroidism

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Do Not Need a Change of Dose

  Dose change was determined by physician according to their clinical judgement.

  2 months (± 2 weeks) after switch to sodium formulation.

Secondary Outcomes (4)

• Magnitude of the Change in Daily Dose Needed

  2 months (± 2 weeks) after switch to sodium formulation.

• Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L

  Month 4 (± 4 weeks) after inclusion into study.

• Absolute Serum Thyroid Stimulating Hormone Values

  Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.

• Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone

  Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.

Study Arms (1)

Levothyroxine sodium new formulation

EXPERIMENTAL

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

Interventions

Levothyroxine sodium new formulation DRUG

Levothyroxine tablets

Levothyroxine sodium new formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Near) total thyroidectomised patients.
• Aged 18 years and older.
• Written informed consent given.
• Able and willing to comply with protocol requirements and to complete the study.

You may not qualify if:

• History of Graves' disease or positive TSH-receptor antibodies.
• History of thyroid cancer requiring TSH suppression.
• Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
• Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
• Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
• Participation in another trial in the past 6 weeks.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Leuven, Belgium

Location

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Responsible

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 20, 2015
• Results First Posted: July 20, 2015

Record last verified: 2015-06

Locations

BE (1)