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

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. Identifier: NCT00151892
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : September 21, 2010
Last Update Posted : March 20, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: SPD476 Drug: Asacol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SPD476
Drug: SPD476
2.4 g/day Once Daily (QD)
Other Names:
  • Lialda
  • mesalazine
  • mesalamine
  • MMX mesalamine

Active Comparator: Asacol Drug: Asacol
1.6g/day administered 800 mg Twice Daily (BID)
Other Name: mesalamine

Primary Outcome Measures :
  1. 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].

Secondary Outcome Measures :
  1. Withdrawal Due to Relapse of UC [ Time Frame: Over 6 Months ]
    Relapse is defined as withdrawal from the study due to lack of efficacy.

  2. 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).

  3. 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.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • proctitis
  • previous resective colonic surgery
  • Crohn's disease
  • hypersensitivity to salicylates
  • moderate/severe renal impairment

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 identifier (NCT number): NCT00151892

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Sponsors and Collaborators
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Principal Investigator: William Sandborn, MD Mayo Clinic
Principal Investigator: Professor Geert D'Haens Imelda General Hospital
Additional Information:
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Responsible Party: Shire Identifier: NCT00151892    
Other Study ID Numbers: SPD476-304
2004-004184-29 ( EudraCT Number )
First Posted: September 9, 2005    Key Record Dates
Results First Posted: September 21, 2010
Last Update Posted: March 20, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents