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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
2004-004184-29
Secondary ID [2] 0 0
SPD476-304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Withdrawal Due to Relapse of UC
Timepoint [1] 0 0
Over 6 Months
Secondary outcome [2] 0 0
Endoscopic Remission of UC With No or Mild Symptoms at 6 Months
Timepoint [2] 0 0
6 Months
Secondary outcome [3] 0 0
Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months
Timepoint [3] 0 0
Baseline and 6 months
Secondary outcome [4] 0 0
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
Timepoint [4] 0 0
6 Months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- proctitis

- previous resective colonic surgery

- Crohn's disease

- hypersensitivity to salicylates

- moderate/severe renal impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/09/2009
Sample size
Target
Accrual to date
Final
829
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Eastern Health Hospital - Box Hill
Recruitment hospital [5] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [6] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Missouri
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Tennessee
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Texas
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Argentina
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Buenos Aires
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Ciudad de Buenos Aires
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Mendoza
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Bonheiden
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Genk
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00151892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries