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Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
This study has been completed.
Sponsored by: Ferring Pharmaceuticals
Information provided by: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00209300
  Purpose

This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.

Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).

Number of Subjects (Planned and Analysed):

  • 360 patients for demonstration of non-inferiority between once daily and twice daily;
  • 326 to be analysed in per-protocol (PP) analyses; and
  • 360 in intention-to-treat (ITT) analyses.

Condition Intervention Phase
Ulcerative Colitis
Drug: Pentasa
Phase III

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Ulcerative Colitis
Drug Information available for: Mesalamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-Centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily

Further study details as provided by Ferring Pharmaceuticals:

Enrollment: 362
Study Start Date: May 2005
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI < 2 at enrollment
  2. Extension of the disease > 15 cm distance from anal verge
  3. Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted.
  4. Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day
  5. 18 years or older
  6. Signed informed consent

Exclusion Criteria:

  1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease
  2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates derivatives
  3. Patients who used mesalazine > 2.5 grams orally in the previous month,
  4. Patients who used rectal mesalazine > 3 grams per week in the previous month
  5. Use of corticosteroids (oral and/or rectal routes) within the last month
  6. Intake of immunosuppressants within the last 3 months
  7. Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values
  8. Patients with history or physical examination findings indicative of active alcohol or drug abuse
  9. Patients with a history of disease, including mental/emotional disorders, that would interfere with their participation in the study
  10. Women who are pregnant or nursing (non-menopausal women who are sexually active and do not use effective contraceptives, as judged by the investigator, must have a negative pregnancy test)
  11. Patients who participated in another clinical study in the last 3 months
  12. Patients who were previously participating in this study
  13. Patients with any other disease that may influence the study assessment, such as malignant disease, etc.
  14. Patients who are unable to comply with any requirements of the protocol
  15. Patients who are unable to write or read local language.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209300

Locations
Germany
Markus Krankenhaus, Frankfurte Diakonie Kliniken, Frankfurt, Germany
Berlin, Germany
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Principal Investigator: Axel U. Dignass, Dr. Prof Markus Krankenhaus, Frankfurter Diakonie Kliniken, Frankfurt, Germany
  More Information

Study ID Numbers: FE999907, CS0003, 2004-004565-15
Study First Received: September 13, 2005
Last Updated: August 9, 2007
ClinicalTrials.gov Identifier: NCT00209300  
Health Authority: Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Ferring Pharmaceuticals:
Ulcerative Colitis for Maintenance of Remission

Study placed in the following topic categories:
Digestive System Diseases
Mesalamine
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009