Calendario›QNCX›Dex 21-P · Crocodex

Dex 21-P · Crocodex

Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis

Ensayo de Quince Therapeutics, Inc. en Colitis ulcerosa.

Más ensayos de: Colitis ulcerosa.

Fase

Fase 2

Estado

Completado

Participantes

33

previstos

Centros

1

Fin del objetivo primario

may 2007

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2003.

Qué mide

The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroObjectives: The primary objective of this trial was to evaluate the patients response rate at the end of the study. Patients were considered responder if one of the following conditions occurs: * Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treatment procedure; * Disease marked improvement versus basal conditions (at least 5 point decrease in Powell Tuck index or 150 point decrease in CDAI score) and withdrawal of oral steroids therapy from at least the second treatment procedure. Secondary objectives: * to evaluate the endogenous cortisole production after receiving the study treatment * to evaluate the inflammatory indexes (ESR and CPR) after receiving the study treatment * to evaluate the endoscopic remission in patients suffering from mesalazine refractory Ulcerative Colitis * to evaluate the safety of dexamethasone intra-erythrocyte therapy with particular attention to steroid-related adverse events.

Más ensayos de QNCX

Todos los de QNCX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01171807), actualizada en sep 2024.