Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Asacol	Asacol	-
SPD476	SPD476	Mesalazine

Primary Outcome Measures

Name	Time	Method
Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months	6 Months	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 \[ulceration; spontaneous bleeding\].

Secondary Outcome Measures

Name	Time	Method
Withdrawal Due to Relapse of UC	Over 6 Months	Relapse is defined as withdrawal from the study due to lack of efficacy.
Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months	Baseline and 6 months	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	6 Months	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.
Endoscopic Remission of UC With No or Mild Symptoms at 6 Months	6 Months	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).

Locations (140): Birmingham Gastroenterology Associates
🇺🇸
Birmingham, Alabama, United States
Connecticut Gastroenterology Institute
🇺🇸
Bristol, Connecticut, United States
Washington Gastroenterology
🇺🇸
Washington, District of Columbia, United States
Southern Clinical Research Consultants
🇺🇸
Hollywood, Florida, United States
Boorland-Groover Clinic
🇺🇸
Jacksonville, Florida, United States
United Medical Research
🇺🇸
New Smyrna Beach, Florida, United States
Atlanta Gastroenterology Associates
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Atlanta, Georgia, United States
Midwest Clinical Research Center
🇺🇸
Moline, Illinois, United States
Gastrointestinal Clinic of Quad Cities
🇺🇸
Davenport, Iowa, United States
Drug Research Services, Inc.
🇺🇸
Metairie, Louisiana, United States
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Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States