Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis|
- Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding].
- Withdrawal Due to Relapse of UC [ Time Frame: Over 6 Months ] [ Designated as safety issue: No ]Relapse is defined as withdrawal from the study due to lack of efficacy.
- Endoscopic Remission of UC With No or Mild Symptoms at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).
- Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.
|Study Start Date:||April 2005|
|Study Completion Date:||October 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
2.4 g/day Once Daily (QD)
Other Name: Lialda, mesalazine, mesalamine, MMX mesalamine
|Active Comparator: Asacol||
1.6g/day administered 800 mg Twice Daily (BID)
Other Name: mesalamine
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|Principal Investigator:||William J Sandborn, MD||Mayo Clinic|
|Principal Investigator:||Professor Geert D'Haens||Imelda General Hospital|