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Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001351-40-IT

Enrollment

Unknown

Registered

2012-08-07

Start date

2012-05-02

Completion date

Unknown

Last updated

2016-10-03

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

Conditions

NA MedDRA version: 14.1 Level: PT Classification code 10048832 Term: Colon adenoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10013549 Term: Diverticulosis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: PENTACOL 800*60CPR 800MG R.M. Pharmaceutical Form: Modified-release tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: NA 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Main Objective: NA;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Italy

Contacts

Public ContactDipartimento Medico

SOFAR SPA

gbartesaghi@sofarfarm.it02 909362231

Outcome results

None listed

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

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