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Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

NCT01277289 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-06-03

Study results available
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Summary

Primary objective:

Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids.

Secondary objectives:

1. safety of EryDex
2. emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients;
3. duration of the period of remission;
4. evaluation of the hypophysis-adrenal function;
5. study of plasma concentrations of dexamethasone;
6. effect of therapy on the metabolism of calcium and on indexes of inflammation;
7. assessing the quality of life;
8. rate of surgical resection
9. evaluation of the indirect costs of care.

Conditions

Interventions

DRUG

Dexamethasone

500 mg/20 ml encapsulated in erythrocytes, every month for 12 months

Sponsors & Collaborators

  • Quince Therapeutics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Angelo Andriulli, MD · Unafilliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-03
Primary Completion
2011-12-30
Completion
2012-06-30

Countries

  • Italy
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277289 on ClinicalTrials.gov