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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151892
• Other study ID #: SPD476-304
• Secondary ID: 2004-004184-29
• Status: Completed
• Phase: Phase 3
• Start date: April 8, 2005
• Est. completion date: September 7, 2009

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: September 7, 2009
• Est. primary completion date: September 7, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• SPD476
2.4 g/day Once Daily (QD)
• Asacol
1.6g/day administered 800 mg Twice Daily (BID)

Locations

Country	Name	City	State
Argentina	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
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Eastern Health Hospital	Box Hill	Victoria
Australia	Concord Hospital	Concord	New South Wales
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	Fremantle Hospital	Fremantle	Western Australia
Belgium	Imelda General Hospital	Bonheiden
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	Heilig Hart ziekenhuis vzw Roeselare-Menen	Roeselare
Brazil	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 Israelita Albert Einstein	Sao Paulo
Brazil	Hospital Sao Paulo	Sao Paulo
Canada	University of Calgary	Calgary	Alberta
Canada	GI Research	Edmonton
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Hópital Hótel-Dieu de Quebec	Quebec City	Quebec
Canada	Toronto Digestive Disease Associates, Inc.	Toronto	Ontario
Chile	Clinica Las Condes	Santiago
Chile	Hospital Clinico P.UC	Santiago
Chile	Hospital del Salvador	Santiago
Chile	Hospital San Juan de Dios	Santiago
Czechia	Fakultni Nemocnice Plzen	Plzen
Czechia	Klinicke Centrum ISCARE I.V.F	Prague
Czechia	NZZ Online 24 s.r.o	Prague
Czechia	Thomavers Hospital	Prague
Czechia	Remedis s.r.o	Praha 4
Czechia	Nemocnice Jablonec nad Nisou p.o	Praha 6
Czechia	Oblastni Nemocnice Pribram	Pribram
Czechia	Nemocnice Tabor A.S.	Tabor
Czechia	Masarykova Nemocnice	Usti nad Labem
Denmark	Bispebjerg Hospital	Copenhagen NV
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Koge University Hospital	Koge
France	CHU de Grenoble	Grenoble
France	Hospital De L'Archet	Nice
France	Hospital Haut Leveque	Pessac
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Universitat des Saarlandes	Homburg
Germany	Gastroenterologische Praxis Prof. Hackelsberger	Wiesbaden
Hungary	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
India	Lifeline Multispeciality Hospital	Chennai
India	Asian Institute of Gastreoenterology	Hyderabaad
India	S.R. Kalla Memorial Gastro & General Hospital	Jaipur
India	Amrita Institute of Medical Sciences	Kochi	Kerala
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
Korea, Republic of	Hallyam University, Sacred Heart Hospital	Anyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Centre	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Kangnam St Mary's Hospital	Seoul
Korea, Republic of	Yonsei University, College of Medicine	Seoul
Mexico	Hospital San Javier	Guadalajara
Mexico	Central de Especialidades Medicas (FIDEPAZ)	La Paz
Mexico	Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)	La Paz	Baja California Sur
Mexico	Mexican Institute of Clinical Research	Mexico City
Mexico	Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán	Mexico DF
Mexico	Hospital Angeles Torreón	Torreon
Netherlands	Orbis Medical Centre	Sittard
Netherlands	Isala Clinics	Zwolle
New Zealand	Shakespeare Specialist Group	Auckland
New Zealand	Waikato DHB Hospital	Hamilton
New Zealand	Tauranga Hospital BOP Medical	Tauranga
New Zealand	Wellington Hospital	Wellington
Peru	Clinica Anglo America	Lima
Peru	Clinica El Golf	Lima
Peru	Hospital Nacional Edgardo Rebagliati Martins	Lima
Peru	Hospital Nacional Guillermo Alemnara Irigoyen	Lima
Poland	Klinika Gastroenterologi	Bialystok
Poland	Klinika Gastroenterologii	Lodz
Poland	Klinika Gastroenterologii	Szczecin
Poland	Miejska Przychodnia Specjalistyczna	Torun
Poland	Katedra i Klinika Gastroenterologii	Warszawa
Portugal	Hospital Sao Marcos	Braga
Portugal	Hospital Egas Moniz	Lisboa
Portugal	Hospital Geral Santo Antonio	Porto
Romania	Colentina Clinical Hospital	Bucharest
Romania	Prf. Dr D. Gerota Emergency Hospital	Bucharest
Romania	Octavian Fodor Clinical Emergency Hospital	Cluj-Napoca
Romania	County Emergency Hospital	Constanta
Romania	Institute of Gastronenterology & Hepatology	Iasi
Romania	Clinical County Emergency Hospital	Targu Mures
Russian Federation	City Hospital #24	Moscow
Russian Federation	City Hospital #51	Moscow
Russian Federation	Scientific Centre of Coloproctology	Moscow
Russian Federation	City Hospital #122	St Petersburg
Russian Federation	Russian Academy of Sciences	St. Petersburg
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
South Africa	Louis Leipoldt Medical Centre	Bellville	Western Cape
South Africa	Kingsbury Hospital	Cape Town
South Africa	Parklands Medical Centre	Durban
South Africa	St Augustine's Hospital	Durban
South Africa	Milpark Hospital	Johannesburg
South Africa	New Groote Schuur Hospital	Observatory	Western Cape
South Africa	Greenacres Hospital	Port Elizabeth
South Africa	2H Arun Place	Somerset West
Spain	Hospital Universitario Germans Trias I Pujol	Badalona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Hospital de Sagunto	Valencia
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Karolinska University Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Sophiahemmet	Stockholm
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Addenbrookes Hospital Department of Gastroenterology	Cambridge
United Kingdom	St. Mark's Hospital	Harrow	Middlesex
United Kingdom	Imperial College School of Medicine	London
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne
United Kingdom	Royal Hallamshire Hospital	Sheffield
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Birmingham Gastroenterology Associates	Birmingham	Alabama
United States	Connecticut Gastroenterology Institute	Bristol	Connecticut
United States	ClinSearch	Chattanooga	Tennessee
United States	Gastrointestinal Clinic of Quad Cities	Davenport	Iowa
United States	Southern Clinical Research Consultants	Hollywood	Florida
United States	S D Khan	Houston	Texas
United States	Boorland-Groover Clinic	Jacksonville	Florida
United States	New York Center for Clinical Research	Lake Success	New York
United States	Drug Research Services, Inc.	Metairie	Louisiana
United States	Center for Digestive and Liver Diseases, Inc	Mexico	Missouri
United States	Midwest Clinical Research Center	Moline	Illinois
United States	United Medical Research	New Smyrna Beach	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington Gastroenterology	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	6 Months
Secondary	Withdrawal Due to Relapse of UC	Relapse is defined as withdrawal from the study due to lack of efficacy.	Over 6 Months
Secondary	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).	6 Months
Secondary	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.	Baseline and 6 months
Secondary	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.	6 Months

External Links

•   FDA recall information
•   FDA-approved label