Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT00151892|
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : September 21, 2010
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: SPD476 Drug: Asacol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||829 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||October 2009|
2.4 g/day Once Daily (QD)
|Active Comparator: Asacol||
1.6g/day administered 800 mg Twice Daily (BID)
Other Name: mesalamine
- Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months [ Time Frame: 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].
- Withdrawal Due to Relapse of UC [ Time Frame: Over 6 Months ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151892
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|Principal Investigator:||William Sandborn, MD||Mayo Clinic|
|Principal Investigator:||Professor Geert D'Haens||Imelda General Hospital|