Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
- Registration Number
- NCT00151892
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 829
- 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
- proctitis
- previous resective colonic surgery
- Crohn's disease
- hypersensitivity to salicylates
- moderate/severe renal impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Asacol Asacol - SPD476 SPD476 Mesalazine
- Primary Outcome Measures
Name Time Method Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months 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 \[ulceration; spontaneous bleeding\].
- Secondary Outcome Measures
Name Time Method Withdrawal Due to Relapse of UC Over 6 Months Relapse is defined as withdrawal from the study due to lack of efficacy.
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score 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.
Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months 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.
Endoscopic Remission of UC With No or Mild Symptoms at 6 Months 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).
Trial Locations
- Locations (140)
Hospital San Juan de Dios
🇨🇱Santiago, Chile
Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, India
Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán
🇲🇽Mexico DF, Mexico
Hospital Angeles Torreón
🇲🇽Torreon, Mexico
Klinika Gastroenterologii
🇵🇱Szczecin, Poland
Hospital Egas Moniz
🇵🇹Lisboa, Portugal
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Toronto Digestive Disease Associates, Inc.
🇨🇦Toronto, Ontario, Canada
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
S D Khan
🇺🇸Houston, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Koge University Hospital
🇩🇰Koge, Denmark
Center for Digestive and Liver Diseases, Inc
🇺🇸Mexico, Missouri, United States
Birmingham Gastroenterology Associates
🇺🇸Birmingham, Alabama, United States
Southern Clinical Research Consultants
🇺🇸Hollywood, Florida, United States
Washington Gastroenterology
🇺🇸Washington, District of Columbia, United States
United Medical Research
🇺🇸New Smyrna Beach, Florida, United States
Boorland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Midwest Clinical Research Center
🇺🇸Moline, Illinois, United States
Drug Research Services, Inc.
🇺🇸Metairie, Louisiana, United States
Gastrointestinal Clinic of Quad Cities
🇺🇸Davenport, Iowa, United States
Centro Integral De Gastroenterologia
🇦🇷Ciudad de Buenos Aires, Argentina
New York Center for Clinical Research
🇺🇸Lake Success, New York, United States
Hospital Italiano de Buenos Aires
🇦🇷Capital Federal, Buenos Aires, Argentina
Concord Hospital
🇦🇺Concord, New South Wales, Australia
Bankstown-Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
Hospital Italiano de Mendoza, FINAMED SA
🇦🇷Mendoza, Argentina
Eastern Health Hospital
🇦🇺Box Hill, Victoria, Australia
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Imelda General Hospital
🇧🇪Bonheiden, Belgium
Ziekenhuis Oost Limburg
🇧🇪Genk, Belgium
Heilig Hart ziekenhuis vzw Roeselare-Menen
🇧🇪Roeselare, Belgium
Hospital de Clinicas
🇧🇷Porto Alegre, Brazil
Unigastro
🇧🇷Castelo, Brazil
Universidade Federal da Bahia - Hospital
🇧🇷Salvador, Brazil
Universidade Federal do Rio de Janeiro
🇧🇷Rio De Janeiro, Brazil
Hospital Israelita Albert Einstein
🇧🇷Sao Paulo, Brazil
Hospital Sao Paulo
🇧🇷Sao Paulo, Brazil
University of Calgary
🇨🇦Calgary, Alberta, Canada
Hópital Hótel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
GI Research
🇨🇦Edmonton, Canada
Clinica Las Condes
🇨🇱Santiago, Chile
Hospital del Salvador
🇨🇱Santiago, Chile
Nemocnice Jablonec nad Nisou p.o
🇨🇿Praha 6, Czechia
Hospital Clinico P.UC
🇨🇱Santiago, Chile
Fakultni Nemocnice Plzen
🇨🇿Plzen, Czechia
Thomavers Hospital
🇨🇿Prague, Czechia
NZZ Online 24 s.r.o
🇨🇿Prague, Czechia
Klinicke Centrum ISCARE I.V.F
🇨🇿Prague, Czechia
Remedis s.r.o
🇨🇿Praha 4, Czechia
Oblastni Nemocnice Pribram
🇨🇿Pribram, Czechia
Bispebjerg Hospital
🇩🇰Copenhagen NV, Denmark
Nemocnice Tabor A.S.
🇨🇿Tabor, Czechia
Masarykova Nemocnice
🇨🇿Usti nad Labem, Czechia
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
CHU de Grenoble
🇫🇷Grenoble, France
Hospital De L'Archet
🇫🇷Nice, France
Hospital Haut Leveque
🇫🇷Pessac, France
Universitat des Saarlandes
🇩🇪Homburg, Germany
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Peterfy Sandor utcai
🇭🇺Budapest, Hungary
Gastroenterologische Praxis Prof. Hackelsberger
🇩🇪Wiesbaden, Germany
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Debreceni Egyetem OEC - III
🇭🇺Debrecen, Hungary
Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia
🇭🇺Eger, Hungary
Lifeline Multispeciality Hospital
🇮🇳Chennai, India
Amrita Institute of Medical Sciences
🇮🇳Kochi, Kerala, India
S.R. Kalla Memorial Gastro & General Hospital
🇮🇳Jaipur, India
Pandy Kalman County Hospital
🇭🇺Gyula, Hungary
Asian Institute of Gastreoenterology
🇮🇳Hyderabaad, India
Dayanand Medical College and Hospital
🇮🇳Ludhiana, India
Hallyam University, Sacred Heart Hospital
🇰🇷Anyang-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Jaslok Hospital and Research Centre
🇮🇳Mumbai, India
Sree Gokulam Medical Centre & Research Foundation
🇮🇳Trivandrum, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Samsung Medical Centre
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Kangnam St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)
🇲🇽La Paz, Baja California Sur, Mexico
Hospital San Javier
🇲🇽Guadalajara, Mexico
Yonsei University, College of Medicine
🇰🇷Seoul, Korea, Republic of
Central de Especialidades Medicas (FIDEPAZ)
🇲🇽La Paz, Mexico
Mexican Institute of Clinical Research
🇲🇽Mexico City, Mexico
Orbis Medical Centre
🇳🇱Sittard, Netherlands
Isala Clinics
🇳🇱Zwolle, Netherlands
Shakespeare Specialist Group
🇳🇿Auckland, New Zealand
Waikato DHB Hospital
🇳🇿Hamilton, New Zealand
Wellington Hospital
🇳🇿Wellington, New Zealand
Tauranga Hospital BOP Medical
🇳🇿Tauranga, New Zealand
Hospital Nacional Guillermo Alemnara Irigoyen
🇵🇪Lima, Peru
Clinica Anglo America
🇵🇪Lima, Peru
Clinica El Golf
🇵🇪Lima, Peru
Hospital Nacional Edgardo Rebagliati Martins
🇵🇪Lima, Peru
Klinika Gastroenterologi
🇵🇱Bialystok, Poland
Miejska Przychodnia Specjalistyczna
🇵🇱Torun, Poland
Katedra i Klinika Gastroenterologii
🇵🇱Warszawa, Poland
Hospital Geral Santo Antonio
🇵🇹Porto, Portugal
Hospital Sao Marcos
🇵🇹Braga, Portugal
Octavian Fodor Clinical Emergency Hospital
🇷🇴Cluj-Napoca, Romania
Institute of Gastronenterology & Hepatology
🇷🇴Iasi, Romania
Colentina Clinical Hospital
🇷🇴Bucharest, Romania
Prf. Dr D. Gerota Emergency Hospital
🇷🇴Bucharest, Romania
County Emergency Hospital
🇷🇴Constanta, Romania
Clinical County Emergency Hospital
🇷🇴Targu Mures, Romania
City Hospital #51
🇷🇺Moscow, Russian Federation
City Hospital #24
🇷🇺Moscow, Russian Federation
City Hospital #122
🇷🇺St Petersburg, Russian Federation
Russian Academy of Sciences
🇷🇺St. Petersburg, Russian Federation
Scientific Centre of Coloproctology
🇷🇺Moscow, Russian Federation
Singapore General Hospital
🇸🇬Singapore, Singapore
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Changi General Hospital
🇸🇬Singapore, Singapore
Kingsbury Hospital
🇿🇦Cape Town, South Africa
Louis Leipoldt Medical Centre
🇿🇦Bellville, Western Cape, South Africa
New Groote Schuur Hospital
🇿🇦Observatory, Western Cape, South Africa
Milpark Hospital
🇿🇦Johannesburg, South Africa
St Augustine's Hospital
🇿🇦Durban, South Africa
Parklands Medical Centre
🇿🇦Durban, South Africa
Greenacres Hospital
🇿🇦Port Elizabeth, South Africa
Hospital Universitario Germans Trias I Pujol
🇪🇸Badalona, Spain
2H Arun Place
🇿🇦Somerset West, South Africa
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital de Sagunto
🇪🇸Valencia, Spain
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Sophiahemmet
🇸🇪Stockholm, Sweden
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
St. Mark's Hospital
🇬🇧Harrow, Middlesex, United Kingdom
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Imperial College School of Medicine
🇬🇧London, United Kingdom
Addenbrookes Hospital Department of Gastroenterology
🇬🇧Cambridge, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
Connecticut Gastroenterology Institute
🇺🇸Bristol, Connecticut, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States