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

June 8, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

829

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad de Buenos Aires, Argentina, C1425EUG
        • Centro Integral De Gastroenterologia
      • Mendoza, Argentina, M5519GLU
        • Hospital Italiano de Mendoza, FINAMED SA
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano de Buenos Aires
  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health Hospital
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda General Hospital
      • Genk, Belgium, 3600
        • Ziekenhuis Oost Limburg
      • Roeselare, Belgium, 8800
        • Heilig Hart ziekenhuis vzw Roeselare-Menen
  • Brazil
      • Castelo, Brazil, 13070-040
        • Unigastro
      • Porto Alegre, Brazil
        • Hospital de Clínicas
      • Rio De Janeiro, Brazil, 21941-290
        • Universidade Federal do Rio de Janeiro
      • Salvador, Brazil, 40110-060
        • Universidade Federal da Bahia - Hospital
      • Sao Paulo, Brazil, 05651-901
        • Hospital israelita Albert Einstein
      • Sao Paulo, Brazil, 01244-020
        • Hospital Sao Paulo
  • Canada
      • Edmonton, Canada, T5H4B9
        • GI Research
    • Alberta
      • Calgary, Alberta, Canada, T2N 4NI
        • University of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M3N2V7
        • Toronto Digestive Disease Associates, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
        • Hopital Maisonneuve-Rosemont
      • Quebec City, Quebec, Canada, G1R 2J6
        • Hópital Hótel-Dieu de Quebec
  • Chile
      • Santiago, Chile, 7591046
        • Clinica Las Condes
      • Santiago, Chile, 7500922
        • Hospital del Salvador
      • Santiago, Chile, 8330024
        • Hospital Clinico P.UC
      • Santiago, Chile, 8350533
        • Hospital San Juan de Dios
  • Czechia
      • Plzen, Czechia, 30460
        • Fakultni Nemocnice Plzen
      • Prague, Czechia, 120 00
        • NZZ Online 24 s.r.o
      • Prague, Czechia, 14059
        • Thomavers Hospital
      • Prague, Czechia, 170 04
        • Klinické Centrum ISCARE I.V.F
      • Praha 4, Czechia, 140 00
        • Remedis s.r.o
      • Praha 6, Czechia, 466 60
        • Nemocnice Jablonec nad Nisou p.o
      • Pribram, Czechia, 261 26
        • Oblastni nemocnice Pribram
      • Tabor, Czechia, 390 03
        • Nemocnice Tábor a.s.
      • Usti nad Labem, Czechia, 401 13
        • Masarykova Nemocnice
  • Denmark
      • Copenhagen NV, Denmark, 1400
        • Bispebjerg Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Koge, Denmark, 4600
        • Koge University Hospital
  • France
      • Grenoble, France
        • CHU de GRENOBLE
      • Nice, France
        • Hospital De L'Archet
      • Pessac, France
        • Hospital Haut levêque
  • Germany
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Homburg, Germany
        • Universität des Saarlandes
      • Wiesbaden, Germany
        • Gastroenterologische Praxis Prof. Hackelsberger
  • Hungary
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem
      • Budapest, Hungary, H-1076
        • Peterfy Sandor utcai
      • Debrecen, Hungary, H-4012
        • Debreceni Egyetem OEC - III
      • Eger, Hungary, H-3300
        • Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia
      • Gyula, Hungary, H-5700
        • Pándy Kálmán County Hospital
  • India
      • Chennai, India, 600096
        • Lifeline multispeciality hospital
      • Hyderabaad, India, 500082
        • Asian Institute of Gastreoenterology
      • Jaipur, India, 302001
        • S.R. Kalla Memorial Gastro & General Hospital
      • Lucknow, India, 226 014
        • Sanjay Gandhi Post Graduate Institute of Medical Sciences
      • Ludhiana, India, 141 001
        • Dayanand Medical College and Hospital
      • Mumbai, India, 400 026
        • Jaslok Hospital and Research Centre
      • New Delhi, India, 110 029
        • All India Institute of Medical Sciences
      • Trivandrum, India, 695607
        • Sree Gokulam Medical Centre & Research Foundation
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Amrita Institute of Medical Sciences
  • Korea, Republic of
      • Anyang-si, Korea, Republic of, 431-070
        • Hallyam University, Sacred Heart Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Centre
      • Seoul, Korea, Republic of, 137-040
        • The Catholic University of Korea Kangnam St Mary's Hospital
      • Seoul, Korea, Republic of
        • Yonsei University, College of Medicine
  • Mexico
      • Guadalajara, Mexico, 44670
        • Hospital San Javier
      • La Paz, Mexico, 23090
        • Central de Especialidades Medicas (FIDEPAZ)
      • Mexico City, Mexico, 6700
        • Mexican Institute of Clinical Research
      • Mexico DF, Mexico, CP 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Torreon, Mexico, 27250
        • Hospital Angeles Torreón
    • Baja California Sur
      • La Paz, Baja California Sur, Mexico, CP23000
        • Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)
  • Netherlands
      • Sittard, Netherlands, 6162 BG
        • Orbis Medical Centre
      • Zwolle, Netherlands, 8025 AB
        • Isala Clinics
  • New Zealand
      • Auckland, New Zealand, 620
        • Shakespeare Specialist Group
      • Hamilton, New Zealand, 2001
        • Waikato DHB Hospital
      • Tauranga, New Zealand, 3112
        • Tauranga Hospital BOP Medical
      • Wellington, New Zealand, 6242
        • Wellington Hospital
  • Peru
      • Lima, Peru, Lima-11
        • Hospital Nacional Edgardo Rebagliati Martins
      • Lima, Peru, Lima-13
        • Hospital Nacional Guillermo Alemnara Irigoyen
      • Lima, Peru, Lima-27
        • Clinica Anglo America
      • Lima, Peru, Lima-27
        • Clinica El Golf
  • Poland
      • Bialystok, Poland
        • Klinika Gastroenterologi
      • Lodz, Poland
        • Klinika Gastroenterologii
      • Szczecin, Poland
        • Klinika Gastroenterologii
      • Torun, Poland
        • Miejska Przychodnia Specjalistyczna
      • Warszawa, Poland
        • Katedra i Klinika Gastroenterologii
  • Portugal
      • Braga, Portugal, 4701-965
        • Hospital Sao Marcos
      • Lisboa, Portugal, 1349-019
        • Hospital Egas Moniz
      • Porto, Portugal, 4099-001
        • Hospital Geral Santo Antonio
  • Romania
      • Bucharest, Romania, 020125
        • Colentina Clinical Hospital
      • Bucharest, Romania, 021392
        • Prf. Dr D. Gerota Emergency Hospital
      • Cluj-Napoca, Romania, 400162
        • Octavian Fodor Clinical Emergency Hospital
      • Constanta, Romania, 900591
        • County Emergency Hospital
      • Iasi, Romania, 700111
        • Institute of Gastronenterology & Hepatology
      • Targu Mures, Romania, 540103
        • Clinical County Emergency Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • City Hospital #24
      • Moscow, Russian Federation
        • City Hospital #51
      • Moscow, Russian Federation
        • Scientific Centre of Coloproctology
      • St Petersburg, Russian Federation
        • City Hospital #122
      • St. Petersburg, Russian Federation
        • Russian Academy of Sciences
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 529889
        • Changi General Hospital
  • South Africa
      • Cape Town, South Africa, 7708
        • Kingsbury Hospital
      • Durban, South Africa, 4091
        • Parklands Medical Centre
      • Durban, South Africa, 4001
        • St Augustine's Hospital
      • Johannesburg, South Africa, 2193
        • Milpark Hospital
      • Port Elizabeth, South Africa, 6057
        • Greenacres Hospital
      • Somerset West, South Africa, 7130
        • 2H Arun Place
    • Western Cape
      • Bellville, Western Cape, South Africa, 7505
        • Louis Leipoldt Medical Centre
      • Observatory, Western Cape, South Africa, 7925
        • New Groote Schuur Hospital
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofía
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Valencia, Spain
        • Hospital de Sagunto
  • Sweden
      • Gothenburg, Sweden, 41345
        • Sahlgrenska University Hospital
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital
      • Stockholm, Sweden, 11486
        • Sophiahemmet
  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital Department of Gastroenterology
      • London, United Kingdom, W12 0NN
        • Imperial College School of Medicine
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • St. Mark's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Gastroenterology Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Gastroenterology
    • Florida
      • Hollywood, Florida, United States, 33021
        • Southern Clinical Research Consultants
      • Jacksonville, Florida, United States, 32256
        • Boorland-Groover Clinic
      • New Smyrna Beach, Florida, United States, 32168
        • United Medical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Moline, Illinois, United States, 61265
        • Midwest Clinical Research Center
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Gastrointestinal Clinic of Quad Cities
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Drug Research Services, Inc.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases, Inc
    • New York
      • Lake Success, New York, United States, 11042
        • New York Center for Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • ClinSearch
    • Texas
      • Houston, Texas, United States, 77090
        • S D Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SPD476
Mesalazine
Drug: SPD476
2.4 g/day Once Daily (QD)
Other Names:
  • mesalamine
  • Lialda
  • mesalazine
  • MMX mesalamine
ACTIVE_COMPARATOR: Asacol
Drug: Asacol
1.6g/day administered 800 mg Twice Daily (BID)
Other Names:
  • mesalamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal Due to Relapse of UC
Time Frame: Over 6 Months
Relapse is defined as withdrawal from the study due to lack of efficacy.
Over 6 Months
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).
6 Months
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.
Baseline and 6 months
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 8, 2005

Primary Completion (ACTUAL)

September 7, 2009

Study Completion (ACTUAL)

September 7, 2009

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (ESTIMATE)

September 9, 2005

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD476-304
  • 2004-004184-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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