Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
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|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.
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): NCT00151892
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|Principal Investigator:||William Sandborn, MD||Mayo Clinic|
|Principal Investigator:||Professor Geert D'Haens||Imelda General Hospital|