Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00151892
First received: September 7, 2005
Last updated: June 6, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colitis, Ulcerative |
Drug: SPD476 Drug: Asacol |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- 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].
Secondary Outcome Measures:
- 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.
| Enrollment: | 829 |
| Study Start Date: | April 2005 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SPD476
Mesalazine
|
Drug: SPD476
2.4 g/day Once Daily (QD)
Other Name: Lialda, mesalazine, mesalamine, MMX mesalamine
|
| Active Comparator: Asacol |
Drug: Asacol
1.6g/day administered 800 mg Twice Daily (BID)
Other Name: mesalamine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151892
Show 142 Study Locations
Show 142 Study LocationsSponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | William J Sandborn, MD | Mayo Clinic |
| Principal Investigator: | Professor Geert D'Haens | Imelda General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Timothy Whitaker, M.D., Shire Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00151892 History of Changes |
| Other Study ID Numbers: | SPD476-304 |
| Study First Received: | September 7, 2005 |
| Results First Received: | August 26, 2010 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Inflammatory Bowel Diseases Pathologic Processes Mesalamine |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013