Phase 4
N=283
Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
Hypothyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01921452 ↗Enrolled (actual)
283
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Number of Participants With Positive and Negative TSH Test Result — 103; 179; 121; 162 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Quantitative POC TSH Kit (Device); Qualitative POC TSH Kit (Device); Third generation TSH Kit (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Positive and Negative TSH Test Result |
103; 179; 121; 162 | — |
| PRIMARY Concentration of TSH in Whole Blood |
7.38; 30.18 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01921452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.