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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01171807
Date of registration: 28/07/2010
Prospective Registration: No
Primary sponsor: Casa Sollievo della Sofferenza IRCCS
Public title: Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis Crocodex
Scientific title: PHASE 2 STUDY OF DEXAMETHASONE 21-PHOSPHATE LOADED INTO AUTOLOGOUS ERYTHROCYTES IN STEROID-DEPENDENT ULCERATIVE COLITIS PATIENTS
Date of first enrolment: April 2003
Target sample size: 40
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01171807
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Italy
Contacts
Name:     Fabrizio Bossa, MD
Address: 
Telephone: 00390882410235
Email: f.bossa@operapadrepio.it
Affiliation: 
Name:     Fabrizio Bossa, MD
Address: 
Telephone: 00390882410235
Email: f.bossa@operapadrepio.it
Affiliation: 
Name:     Angelo Andriulli, MD
Address: 
Telephone:
Email:
Affiliation:  Casa Sollievo della Sofferenza Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- adult patients

- steroid-dependent ulcerative colitis

- clinical remission or mild clinical activity

Exclusion Criteria:

- uncontrolled diabetes

- severe comorbidities (renal failure, heart failure, cirrhosis, neoplasia)

- previous exposure to biologic therapy

- pregnancy of breast feeding

- alcohol or drug abuse

- mental illness



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Drug: Dexamethasone 21-phosphate
Primary Outcome(s)
The proportion of patients able to discontinue oral corticosteroids while maintaining clinical remission or stable condition [Time Frame: 6 months]
Secondary Outcome(s)
The modification of biochemical and endoscopic parameters [Time Frame: 6 months]
The pharmacokinetics of Dex 21-P loaded into red blood cells [Time Frame: 1 month]
The proportion of patients with disappearance of steroid-related events [Time Frame: 6 months]
Secondary ID(s)
Crocodex
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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