- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01197183
Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France (ORCHIDEE)
Survey for the Initial Treatment of Hypothyroidism in France
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Thyroid disorder can be central, caused by a deficiency in thyroid stimulating hormone (TSH) production; or peripheral, caused by the decrease in the plasma concentration of thyroid hormones, more specifically of free thyroxine (free T4). Peripheral hypothyroidism is caused by the decrease in the production capacities of the thyroid gland.
The treatment of hypothyroidism is based on the restoration and maintenance of biological (judged on the basis of the standardised TSH and T4 values) and clinical euthyroidism.
A number of forms of thyroid hormones are available in the French market (Euthyral®, Cynomel®, L-thyroxine drops®), of which, Levothyrox® is the most frequently prescribed drug in this category.
The treatment of peripheral hypothyroidism, in particular, is well codified and almost consensual. In France, there is no published observational study, based on which one can document the manner in which subjects are treated. This observational study is set up to document these practices.
OBJECTIVES The principal objectives of this survey is to to get information on the use of Levothyrox in France
- Circumstances of diagnosis
- Record realised
- Terms and conditions of treatment by the general practitioner and/or the endocrinologist
The secondary objective is to evaluate the inclusion criteria for levothyroxine treatment.
For each subject the participating doctor will complete a follow up questionnaire form until the first control level of TSH after the diagnosis of hypothyroidism.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Lyon
-
Saint Romain, Lyon, Frankrike, 69008
- Merck Lipha Santé Laboratories
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Recently diagnosed hypothyroid subject (either during the inclusion period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor
- Subject, who has given his/her oral consent for participation
Exclusion Criteria:
- Subject included in clinical trial or having participated in a clinical trial during the last 3 months
- Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term)
- All contraindications to Lévothyrox
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Initial questionnaire
Tidsramme: Baseline
|
Documentation of indications for levothyroxine treatment
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Follow-up questionnaire
Tidsramme: 3 months
|
Documentaion of inclusion criteria (socio-demographic and clinical data, treatment information and biological values) for levothyroxine treatment.
Follow-up questionnaire filled-in until the result of the first TSH level after commencement of therapy with thyroid hormones.
|
3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Dr. Frederic Landron, MD, Laboratoires Merck Lipha Santé
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 200007-502
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .