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OpenTrials
Completed

NCT Number: NCT01104753

A Study of Pentasa in Patients With Ulcerative Colitis

Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Brandýs n/Lab., Brandýs nad Labem, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from ulcerative colitis

Exclusion criteria

  • Hypersensitivity to mesalazine, salicylates or to any excipient
  • Severe damage to liver or renal functions

Treatment and study plan

Primary outcomes

  1. Verify the safety profile

    Time frame: 1 year

    • Number of AEs/SAEs
    • Intensity and seriousness of reported AEs/SAEs

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Apr 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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