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

NCT ID: NCT00151892

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 829 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-08
• Study Completion Date: 2009-09-07

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SPD476

Mesalazine

Group Type: EXPERIMENTAL

SPD476

Intervention Type: DRUG

2.4 g/day Once Daily (QD)

Asacol

Group Type: ACTIVE_COMPARATOR

Asacol

Intervention Type: DRUG

1.6g/day administered 800 mg Twice Daily (BID)

Interventions

SPD476

2.4 g/day Once Daily (QD)

Intervention Type: DRUG

Asacol

1.6g/day administered 800 mg Twice Daily (BID)

Intervention Type: DRUG

Other Intervention Names

Lialda; mesalazine; mesalamine; MMX mesalamine; mesalamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Connecticut Gastroenterology Institute

Bristol, Connecticut, United States

Washington Gastroenterology

Washington D.C., District of Columbia, United States

Southern Clinical Research Consultants

Hollywood, Florida, United States

Boorland-Groover Clinic

Jacksonville, Florida, United States

United Medical Research

New Smyrna Beach, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Midwest Clinical Research Center

Moline, Illinois, United States

Gastrointestinal Clinic of Quad Cities

Davenport, Iowa, United States

Drug Research Services, Inc.

Metairie, Louisiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Center for Digestive and Liver Diseases, Inc

Mexico, Missouri, United States

New York Center for Clinical Research

Lake Success, New York, United States

ClinSearch

Chattanooga, Tennessee, United States

S D Khan

Houston, Texas, United States

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, Argentina

Centro Integral De Gastroenterologia

Ciudad de Buenos Aires, , Argentina

Hospital Italiano de Mendoza, FINAMED SA

Mendoza, , Argentina

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Concord Hospital

Concord, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Eastern Health Hospital

Box Hill, Victoria, Australia

St Vincent's Hospital

Fitzroy, Victoria, Australia

Fremantle Hospital

Fremantle, Western Australia, Australia

Imelda General Hospital

Bonheiden, , Belgium

Ziekenhuis Oost Limburg

Genk, , Belgium

Heilig Hart ziekenhuis vzw Roeselare-Menen

Roeselare, , Belgium

Unigastro

Castelo, , Brazil

Hospital de Clinicas

Porto Alegre, , Brazil

Universidade Federal do Rio de Janeiro

Rio de Janeiro, , Brazil

Universidade Federal da Bahia - Hospital

Salvador, , Brazil

Hospital Sao Paulo

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , Brazil

University of Calgary

Calgary, Alberta, Canada

Toronto Digestive Disease Associates, Inc.

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Hópital Hótel-Dieu de Quebec

Québec, Quebec, Canada

GI Research

Edmonton, , Canada

Hospital del Salvador

Santiago, , Chile

Clinica Las Condes

Santiago, , Chile

Hospital Clinico P.UC

Santiago, , Chile

Hospital San Juan de Dios

Santiago, , Chile

Fakultni Nemocnice Plzen

Pilsen, , Czechia

NZZ Online 24 s.r.o

Prague, , Czechia

Remedis s.r.o

Prague, , Czechia

Thomavers Hospital

Prague, , Czechia

Klinicke Centrum ISCARE I.V.F

Prague, , Czechia

Nemocnice Jablonec nad Nisou p.o

Prague, , Czechia

Oblastni Nemocnice Pribram

Příbram, , Czechia

Nemocnice Tabor A.S.

Tábor, , Czechia

Masarykova Nemocnice

Ústí nad Labem, , Czechia

Bispebjerg Hospital

Copenhagen NV, , Denmark

Hvidovre Hospital

Hvidovre, , Denmark

Koge University Hospital

Køge, , Denmark

CHU de Grenoble

Grenoble, , France

Hospital De L'Archet

Nice, , France

Hospital Haut Leveque

Pessac, , France

Universitatsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitat des Saarlandes

Homburg, , Germany

Gastroenterologische Praxis Prof. Hackelsberger

Wiesbaden, , Germany

Peterfy Sandor utcai

Budapest, , Hungary

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem OEC - III

Debrecen, , Hungary

Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

Eger, , Hungary

Pandy Kalman County Hospital

Gyula, , Hungary

Amrita Institute of Medical Sciences

Kochi, Kerala, India

Lifeline Multispeciality Hospital

Chennai, , India

Asian Institute of Gastreoenterology

Hyderabaad, , India

S.R. Kalla Memorial Gastro & General Hospital

Jaipur, , India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, , India

Dayanand Medical College and Hospital

Ludhiana, , India

Jaslok Hospital and Research Centre

Mumbai, , India

All India Institute of Medical Sciences

New Delhi, , India

Sree Gokulam Medical Centre & Research Foundation

Trivandrum, , India

Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

La Paz, Baja California Sur, Mexico

Hospital San Javier

Guadalajara, , Mexico

Central de Especialidades Medicas (FIDEPAZ)

La Paz, , Mexico

Mexican Institute of Clinical Research

Mexico City, , Mexico

Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Hospital Angeles Torreón

Torreón, , Mexico

Orbis Medical Centre

Sittard, , Netherlands

Isala Clinics

Zwolle, , Netherlands

Shakespeare Specialist Group

Auckland, , New Zealand

Waikato DHB Hospital

Hamilton, , New Zealand

Tauranga Hospital BOP Medical

Tauranga, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Hospital Nacional Edgardo Rebagliati Martins

Lima, , Peru

Hospital Nacional Guillermo Alemnara Irigoyen

Lima, , Peru

Clinica Anglo America

Lima, , Peru

Clinica El Golf

Lima, , Peru

Klinika Gastroenterologi

Bialystok, , Poland

Klinika Gastroenterologii

Lodz, , Poland

Klinika Gastroenterologii

Szczecin, , Poland

Miejska Przychodnia Specjalistyczna

Torun, , Poland

Katedra i Klinika Gastroenterologii

Warsaw, , Poland

Hospital Sao Marcos

Braga, , Portugal

Hospital Egas Moniz

Lisbon, , Portugal

Hospital Geral Santo Antonio

Porto, , Portugal

Colentina Clinical Hospital

Bucharest, , Romania

Prf. Dr D. Gerota Emergency Hospital

Bucharest, , Romania

Octavian Fodor Clinical Emergency Hospital

Cluj-Napoca, , Romania

County Emergency Hospital

Constanța, , Romania

Institute of Gastronenterology & Hepatology

Iași, , Romania

Clinical County Emergency Hospital

Târgu Mureş, , Romania

City Hospital #24

Moscow, , Russia

City Hospital #51

Moscow, , Russia

Scientific Centre of Coloproctology

Moscow, , Russia

City Hospital #122

Saint Petersburg, , Russia

Russian Academy of Sciences

Saint Petersburg, , Russia

Singapore General Hospital

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Louis Leipoldt Medical Centre

Bellville, Western Cape, South Africa

New Groote Schuur Hospital

Observatory, Western Cape, South Africa

Kingsbury Hospital

Cape Town, , South Africa

St Augustine's Hospital

Durban, , South Africa

Parklands Medical Centre

Durban, , South Africa

Milpark Hospital

Johannesburg, , South Africa

Greenacres Hospital

Port Elizabeth, , South Africa

2H Arun Place

Somerset West, , South Africa

Hallyam University, Sacred Heart Hospital

Anyang-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Samsung Medical Centre

Seoul, , South Korea

The Catholic University of Korea Kangnam St Mary's Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Yonsei University, College of Medicine

Seoul, , South Korea

Hospital Universitario Germans Trias I Pujol

Badalona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario Ramon Y Cajal

Madrid, , Spain

Hospital de Sagunto

Valencia, , Spain

Sahlgrenska University Hospital

Gothenburg, , Sweden

Sophiahemmet

Stockholm, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

St. Mark's Hospital

Harrow, Middlesex, United Kingdom

Addenbrookes Hospital Department of Gastroenterology

Cambridge, , United Kingdom

Imperial College School of Medicine

London, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; Czechia; Denmark; France; Germany; Hungary; India; Mexico; Netherlands; New Zealand; Peru; Poland; Portugal; Romania; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Taiwan; United Kingdom

Related Links

http://www.lialda.com/Professional/pdf/pi.pdf

FDA-approved label

http://www.fda.gov/opacom/7alerts.html

FDA recall information

Other Identifiers

2004-004184-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPD476-304

Identifier Type: -

Identifier Source: org_study_id