Clinical trial NCT00151892: Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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