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Mesalazine (PENTASA®) in Ulcerative Colitis (MUKOSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517607
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : October 1, 2015
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.

Condition or disease Intervention/treatment
Ulcerative Colitis Other: Mesalazine

Study Type : Observational
Actual Enrollment : 506 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice
Study Start Date : February 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Mesalazine Other: Mesalazine
Patient's treated with oral Mesalazine

Primary Outcome Measures :
  1. Patient compliance: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ]

Secondary Outcome Measures :
  1. Patient's level of information: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ]
  2. Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ]
  3. Reasons for the therapeutic decision of the physician: Measured by physician responses [ Time Frame: Month 0 ]
  4. Laboratory parameters of predefined blood measurements [ Time Frame: Month 0- Month 12 ]
    Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT)

  5. Ulcerative Colitis Disease Activity Index (UCDAI) [ Time Frame: Month 0 - Month 12 ]
    UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)

  6. Adverse drug reactions: measured by number of patients and event severity [ Time Frame: Month 0 - Month 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care facilities

Inclusion Criteria:

  • Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or
  • Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®,
  • The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517607

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Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01517607     History of Changes
Other Study ID Numbers: 000027
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents