Back to resultsEfficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SPD476
Asacol
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
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
Sites / Locations
- Birmingham Gastroenterology Associates
- Connecticut Gastroenterology Institute
- Washington Gastroenterology
- Southern Clinical Research Consultants
- Boorland-Groover Clinic
- United Medical Research
- Atlanta Gastroenterology Associates
- Midwest Clinical Research Center
- Gastrointestinal Clinic of Quad Cities
- Drug Research Services, Inc.
- Mayo Clinic
- Center for Digestive and Liver Diseases, Inc
- New York Center for Clinical Research
- ClinSearch
- S D Khan
- Hospital Italiano de Buenos Aires
- Centro Integral De Gastroenterologia
- Hospital Italiano de Mendoza, FINAMED SA
- Bankstown-Lidcombe Hospital
- Concord Hospital
- Royal Adelaide Hospital
- Eastern Health Hospital
- St Vincent's Hospital
- Fremantle Hospital
- Imelda General Hospital
- Ziekenhuis Oost Limburg
- Heilig Hart ziekenhuis vzw Roeselare-Menen
- Unigastro
- Hospital de Clinicas
- Universidade Federal do Rio de Janeiro
- Universidade Federal da Bahia - Hospital
- Hospital Sao Paulo
- Hospital Israelita Albert Einstein
- University of Calgary
- Toronto Digestive Disease Associates, Inc.
- Hopital Maisonneuve-Rosemont
- Hópital Hótel-Dieu de Quebec
- GI Research
- Hospital del Salvador
- Clinica Las Condes
- Hospital Clinico P.UC
- Hospital San Juan de Dios
- Fakultni Nemocnice Plzen
- NZZ Online 24 s.r.o
- Thomavers Hospital
- Klinicke Centrum ISCARE I.V.F
- Remedis s.r.o
- Nemocnice Jablonec nad Nisou p.o
- Oblastni Nemocnice Pribram
- Nemocnice Tabor A.S.
- Masarykova Nemocnice
- Bispebjerg Hospital
- Hvidovre Hospital
- Koge University Hospital
- CHU de Grenoble
- Hospital De L'Archet
- Hospital Haut Leveque
- Universitatsklinikum Freiburg
- Universitat des Saarlandes
- Gastroenterologische Praxis Prof. Hackelsberger
- Peterfy Sandor utcai
- Semmelweis Egyetem
- Debreceni Egyetem OEC - III
- Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia
- Pandy Kalman County Hospital
- Amrita Institute of Medical Sciences
- Lifeline Multispeciality Hospital
- Asian Institute of Gastreoenterology
- S.R. Kalla Memorial Gastro & General Hospital
- Sanjay Gandhi Post Graduate Institute of Medical Sciences
- Dayanand Medical College and Hospital
- Jaslok Hospital and Research Centre
- All India Institute of Medical Sciences
- Sree Gokulam Medical Centre & Research Foundation
- Hallyam University, Sacred Heart Hospital
- Seoul National University Hospital
- Samsung Medical Centre
- The Catholic University of Korea Kangnam St Mary's Hospital
- Asan Medical Center
- Yonsei University, College of Medicine
- Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)
- Hospital San Javier
- Central de Especialidades Medicas (FIDEPAZ)
- Mexican Institute of Clinical Research
- Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán
- Hospital Angeles Torreón
- Orbis Medical Centre
- Isala Clinics
- Shakespeare Specialist Group
- Waikato DHB Hospital
- Tauranga Hospital BOP Medical
- Wellington Hospital
- Hospital Nacional Edgardo Rebagliati Martins
- Hospital Nacional Guillermo Alemnara Irigoyen
- Clinica Anglo America
- Clinica El Golf
- Klinika Gastroenterologi
- Klinika Gastroenterologii
- Klinika Gastroenterologii
- Miejska Przychodnia Specjalistyczna
- Katedra i Klinika Gastroenterologii
- Hospital Sao Marcos
- Hospital Egas Moniz
- Hospital Geral Santo Antonio
- Colentina Clinical Hospital
- Prf. Dr D. Gerota Emergency Hospital
- Octavian Fodor Clinical Emergency Hospital
- County Emergency Hospital
- Institute of Gastronenterology & Hepatology
- Clinical County Emergency Hospital
- City Hospital #24
- City Hospital #51
- Scientific Centre of Coloproctology
- City Hospital #122
- Russian Academy of Sciences
- Singapore General Hospital
- Tan Tock Seng Hospital
- Changi General Hospital
- Louis Leipoldt Medical Centre
- New Groote Schuur Hospital
- Kingsbury Hospital
- St Augustine's Hospital
- Parklands Medical Centre
- Milpark Hospital
- Greenacres Hospital
- 2H Arun Place
- Hospital Universitario Germans Trias I Pujol
- Hospital Universitario Reina Sofia
- Hospital Universitario Ramon Y Cajal
- Hospital de Sagunto
- Sahlgrenska University Hospital
- Sophiahemmet
- Karolinska University Hospital
- Karolinska University Hospital
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- St. Mark's Hospital
- Addenbrookes Hospital Department of Gastroenterology
- Imperial College School of Medicine
- Royal Victoria Infirmary
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SPD476
Asacol
Arm Description
Mesalazine
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Withdrawal Due to Relapse of UC
Relapse is defined as withdrawal from the study due to lack of efficacy.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151892
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 8, 2005 (Actual)
Primary Completion Date
September 7, 2009 (Actual)
Study Completion Date
September 7, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
829 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD476
Arm Type
Experimental
Arm Description
Mesalazine
Arm Title
Asacol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SPD476
Other Intervention Name(s)
Lialda, mesalazine, mesalamine, MMX mesalamine
Intervention Description
2.4 g/day Once Daily (QD)
Intervention Type
Drug
Intervention Name(s)
Asacol
Other Intervention Name(s)
mesalamine
Intervention Description
1.6g/day administered 800 mg Twice Daily (BID)
Primary Outcome Measure Information:
Title
Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
Description
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].
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Withdrawal Due to Relapse of UC
Description
Relapse is defined as withdrawal from the study due to lack of efficacy.
Time Frame
Over 6 Months
Title
Endoscopic Remission of UC With No or Mild Symptoms at 6 Months
Description
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).
Time Frame
6 Months
Title
Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months
Description
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.
Time Frame
Baseline and 6 months
Title
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
Description
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.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastroenterology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Washington Gastroenterology
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Southern Clinical Research Consultants
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Boorland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Midwest Clinical Research Center
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Gastrointestinal Clinic of Quad Cities
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Drug Research Services, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
S D Khan
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Centro Integral De Gastroenterologia
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1425EUG
Country
Argentina
Facility Name
Hospital Italiano de Mendoza, FINAMED SA
City
Mendoza
ZIP/Postal Code
M5519GLU
Country
Argentina
Facility Name
Bankstown-Lidcombe Hospital
City
Bankstown
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Concord Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Eastern Health Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Imelda General Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Ziekenhuis Oost Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Heilig Hart ziekenhuis vzw Roeselare-Menen
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Unigastro
City
Castelo
ZIP/Postal Code
13070-040
Country
Brazil
Facility Name
Hospital de Clinicas
City
Porto Alegre
Country
Brazil
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio De Janeiro
ZIP/Postal Code
21941-290
Country
Brazil
Facility Name
Universidade Federal da Bahia - Hospital
City
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
01244-020
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4NI
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N2V7
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada
Facility Name
Hópital Hótel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
GI Research
City
Edmonton
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
Hospital del Salvador
City
Santiago
ZIP/Postal Code
7500922
Country
Chile
Facility Name
Clinica Las Condes
City
Santiago
ZIP/Postal Code
7591046
Country
Chile
Facility Name
Hospital Clinico P.UC
City
Santiago
ZIP/Postal Code
8330024
Country
Chile
Facility Name
Hospital San Juan de Dios
City
Santiago
ZIP/Postal Code
8350533
Country
Chile
Facility Name
Fakultni Nemocnice Plzen
City
Plzen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
NZZ Online 24 s.r.o
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Thomavers Hospital
City
Prague
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Klinicke Centrum ISCARE I.V.F
City
Prague
ZIP/Postal Code
170 04
Country
Czechia
Facility Name
Remedis s.r.o
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Nemocnice Jablonec nad Nisou p.o
City
Praha 6
ZIP/Postal Code
466 60
Country
Czechia
Facility Name
Oblastni Nemocnice Pribram
City
Pribram
ZIP/Postal Code
261 26
Country
Czechia
Facility Name
Nemocnice Tabor A.S.
City
Tabor
ZIP/Postal Code
390 03
Country
Czechia
Facility Name
Masarykova Nemocnice
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Bispebjerg Hospital
City
Copenhagen NV
ZIP/Postal Code
1400
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Koge University Hospital
City
Koge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
Hospital De L'Archet
City
Nice
Country
France
Facility Name
Hospital Haut Leveque
City
Pessac
Country
France
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Universitat des Saarlandes
City
Homburg
Country
Germany
Facility Name
Gastroenterologische Praxis Prof. Hackelsberger
City
Wiesbaden
Country
Germany
Facility Name
Peterfy Sandor utcai
City
Budapest
ZIP/Postal Code
H-1076
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Debreceni Egyetem OEC - III
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia
City
Eger
ZIP/Postal Code
H-3300
Country
Hungary
Facility Name
Pandy Kalman County Hospital
City
Gyula
ZIP/Postal Code
H-5700
Country
Hungary
Facility Name
Amrita Institute of Medical Sciences
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682 026
Country
India
Facility Name
Lifeline Multispeciality Hospital
City
Chennai
ZIP/Postal Code
600096
Country
India
Facility Name
Asian Institute of Gastreoenterology
City
Hyderabaad
ZIP/Postal Code
500082
Country
India
Facility Name
S.R. Kalla Memorial Gastro & General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Sanjay Gandhi Post Graduate Institute of Medical Sciences
City
Lucknow
ZIP/Postal Code
226 014
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Ludhiana
ZIP/Postal Code
141 001
Country
India
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
ZIP/Postal Code
400 026
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Sree Gokulam Medical Centre & Research Foundation
City
Trivandrum
ZIP/Postal Code
695607
Country
India
Facility Name
Hallyam University, Sacred Heart Hospital
City
Anyang-si
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Centre
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Kangnam St Mary's Hospital
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University, College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)
City
La Paz
State/Province
Baja California Sur
ZIP/Postal Code
CP23000
Country
Mexico
Facility Name
Hospital San Javier
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Central de Especialidades Medicas (FIDEPAZ)
City
La Paz
ZIP/Postal Code
23090
Country
Mexico
Facility Name
Mexican Institute of Clinical Research
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán
City
Mexico DF
ZIP/Postal Code
CP 14000
Country
Mexico
Facility Name
Hospital Angeles Torreón
City
Torreon
ZIP/Postal Code
27250
Country
Mexico
Facility Name
Orbis Medical Centre
City
Sittard
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Isala Clinics
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Shakespeare Specialist Group
City
Auckland
ZIP/Postal Code
620
Country
New Zealand
Facility Name
Waikato DHB Hospital
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
Tauranga Hospital BOP Medical
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6242
Country
New Zealand
Facility Name
Hospital Nacional Edgardo Rebagliati Martins
City
Lima
ZIP/Postal Code
Lima-11
Country
Peru
Facility Name
Hospital Nacional Guillermo Alemnara Irigoyen
City
Lima
ZIP/Postal Code
Lima-13
Country
Peru
Facility Name
Clinica Anglo America
City
Lima
ZIP/Postal Code
Lima-27
Country
Peru
Facility Name
Clinica El Golf
City
Lima
ZIP/Postal Code
Lima-27
Country
Peru
Facility Name
Klinika Gastroenterologi
City
Bialystok
Country
Poland
Facility Name
Klinika Gastroenterologii
City
Lodz
Country
Poland
Facility Name
Klinika Gastroenterologii
City
Szczecin
Country
Poland
Facility Name
Miejska Przychodnia Specjalistyczna
City
Torun
Country
Poland
Facility Name
Katedra i Klinika Gastroenterologii
City
Warszawa
Country
Poland
Facility Name
Hospital Sao Marcos
City
Braga
ZIP/Postal Code
4701-965
Country
Portugal
Facility Name
Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital Geral Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Prf. Dr D. Gerota Emergency Hospital
City
Bucharest
ZIP/Postal Code
021392
Country
Romania
Facility Name
Octavian Fodor Clinical Emergency Hospital
City
Cluj-Napoca
ZIP/Postal Code
400162
Country
Romania
Facility Name
County Emergency Hospital
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Institute of Gastronenterology & Hepatology
City
Iasi
ZIP/Postal Code
700111
Country
Romania
Facility Name
Clinical County Emergency Hospital
City
Targu Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
City Hospital #24
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #51
City
Moscow
Country
Russian Federation
Facility Name
Scientific Centre of Coloproctology
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #122
City
St Petersburg
Country
Russian Federation
Facility Name
Russian Academy of Sciences
City
St. Petersburg
Country
Russian Federation
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Louis Leipoldt Medical Centre
City
Bellville
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
New Groote Schuur Hospital
City
Observatory
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Kingsbury Hospital
City
Cape Town
ZIP/Postal Code
7708
Country
South Africa
Facility Name
St Augustine's Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Parklands Medical Centre
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Milpark Hospital
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Greenacres Hospital
City
Port Elizabeth
ZIP/Postal Code
6057
Country
South Africa
Facility Name
2H Arun Place
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital Universitario Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital de Sagunto
City
Valencia
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Sophiahemmet
City
Stockholm
ZIP/Postal Code
11486
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
St. Mark's Hospital
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Addenbrookes Hospital Department of Gastroenterology
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Imperial College School of Medicine
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.lialda.com/Professional/pdf/pi.pdf
Description
FDA-approved label
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA recall information
Learn more about this trial
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
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