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Mesalazine (PENTASA®) in Ulcerative Colitis (MUKOSA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517607
First Posted: January 25, 2012
Last Update Posted: October 1, 2015
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.
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
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 Intervention
Ulcerative Colitis Other: Mesalazine

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

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

Secondary Outcome Measures:
  • Patient's level of information: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ]
  • Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ]
  • Reasons for the therapeutic decision of the physician: Measured by physician responses [ Time Frame: Month 0 ]
  • 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)

  • 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)

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

Enrollment: 506
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mesalazine Other: Mesalazine
Patient's treated with oral Mesalazine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01517607


  Show 149 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01517607     History of Changes
Other Study ID Numbers: 000027
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: October 1, 2015
Last Verified: September 2015

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