Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit

Phase 4

Completed

• Conditions: Hypothyroidism
• Interventions: Device: Quantitative POC TSH Kit; Device: Qualitative POC TSH Kit; Device: Third generation TSH Kit

• Registration Number: NCT01921452
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-09
• Study First Posted: 2013-08-13
• Study Start: 2013-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-11
• Results First Submitted: 2014-11-20
• Results First Submitted QC: 2014-11-20
• Last Update Submitted: 2014-11-20
• Results First Posted: 2014-11-25
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

• Suspected hypothyroidism subject
• Willing to comply with the trial protocol
• Signed informed consent document

Exclusion Criteria

• Menstrual period, bleeding hemorrhoids, hematuria
• Drinking or taking aspirin within 48 hours
• Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
• Subjects who are unwilling or unable to complete the trial
• Subjects who do not sign informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
POC TSH Kits + Third Generation TSH Kit	Third generation TSH Kit	-
POC TSH Kits + Third Generation TSH Kit	Quantitative POC TSH Kit	-
POC TSH Kits + Third Generation TSH Kit	Qualitative POC TSH Kit	-

Primary Outcome Measures

Name	Time	Method
Concentration of TSH in Whole Blood	Day 1 up to Day 5
Number of Participants With Positive and Negative TSH Test Result	Day 1 up to Day 5

Trial Locations

Locations (1)

Research site; 🇨🇳 Shanghai, China