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Mesalazine (PENTASA®) in Ulcerative Colitis (MUKOSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01517607
First received: January 20, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's level of information: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ] [ Designated as safety issue: No ]
  • Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire [ Time Frame: Month 0 - Month 12 ] [ Designated as safety issue: No ]
  • Reasons for the therapeutic decision of the physician: Measured by physician responses [ Time Frame: Month 0 ] [ Designated as safety issue: No ]
  • Laboratory parameters of predefined blood measurements [ Time Frame: Month 0- Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517607

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01517607     History of Changes
Other Study ID Numbers: 000027
Study First Received: January 20, 2012
Last Updated: April 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013