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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00151892
Registration number
NCT00151892
Ethics application status
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
14/06/2021
Titles & IDs
Public title
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
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Scientific 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
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Secondary ID [1]
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0
2004-004184-29
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Secondary ID [2]
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0
SPD476-304
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPD476
Treatment: Drugs - Asacol
Experimental: SPD476 - Mesalazine
Active comparator: Asacol -
Treatment: Drugs: SPD476
2.4 g/day Once Daily (QD)
Treatment: Drugs: Asacol
1.6g/day administered 800 mg Twice Daily (BID)
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
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Assessment method [1]
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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 \[ulceration; spontaneous bleeding\].
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Timepoint [1]
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6 Months
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Secondary outcome [1]
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Withdrawal Due to Relapse of UC
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Assessment method [1]
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Relapse is defined as withdrawal from the study due to lack of efficacy.
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Timepoint [1]
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Over 6 Months
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Secondary outcome [2]
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Endoscopic Remission of UC With No or Mild Symptoms at 6 Months
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Assessment method [2]
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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).
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Timepoint [2]
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6 Months
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Secondary outcome [3]
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Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and 6 months
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Secondary outcome [4]
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Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
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Assessment method [4]
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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.
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Timepoint [4]
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6 Months
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* proctitis
* previous resective colonic surgery
* Crohn's disease
* hypersensitivity to salicylates
* moderate/severe renal impairment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/09/2009
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Sample size
Target
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Accrual to date
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Final
829
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Bankstown-Lidcombe Hospital - Bankstown
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Concord Hospital - Concord
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Royal Adelaide Hospital - Adelaide
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Eastern Health Hospital - Box Hill
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St Vincent's Hospital - Fitzroy
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Fremantle Hospital - Fremantle
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2200 - Bankstown
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2139 - Concord
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5000 - Adelaide
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3128 - Box Hill
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3065 - Fitzroy
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
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Name
Shire
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00151892
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Contacts
Principal investigator
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Takeda
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00151892
Download to PDF