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Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003471-20-IT
Enrollment
Unknown
Registered
2007-01-17
Start date
2005-12-07
Completion date
Unknown
Last updated
2013-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ULCERATIVE COLITIS MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Propionyl-L-carnitine Product Code: ST261 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Levocarnitine CAS Number: 119793-66-3 Concentration unit: % percent Concentrat

Sponsors

SIGMA-TAU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026