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Mesalazine (PENTASA®) in Ulcerative Colitis (MUKOSA)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01517607
First received: January 20, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

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 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 25, 2014