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Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209300
First Posted: September 21, 2005
Last Update Posted: May 19, 2011
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.
Information provided by:
Ferring Pharmaceuticals
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Enrollment: 362
Study Start Date: May 2005
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

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
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
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): NCT00209300


  Show 69 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00209300     History of Changes
Other Study ID Numbers: FE999907 CS003
2004-004565-15
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: May 19, 2011
Last Verified: May 2011

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

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