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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00151892




Registration number
NCT00151892
Ethics application status
Date submitted
7/09/2005
Date registered
9/09/2005
Date last updated
20/03/2017

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 - 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].
Timepoint [1] 0 0
6 Months
Secondary outcome [1] 0 0
Withdrawal Due to Relapse of UC - Relapse is defined as withdrawal from the study due to lack of efficacy.
Timepoint [1] 0 0
Over 6 Months
Secondary outcome [2] 0 0
Endoscopic Remission of UC With No or Mild Symptoms at 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).
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 - 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.
Timepoint [3] 0 0
Baseline and 6 months
Secondary outcome [4] 0 0
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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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/show/NCT00151892
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Sandborn, MD
Address 0 0
Mayo Clinic
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

Summary results
Other publications