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

NCT00151892 | Completed Phase 3 Results

• 2 other identifiers: SPD476-3042004-004184-29
• Study Type: interventional
• Target: 829
• Locations: 28 countries
• Sites: 142

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Withdrawal Due to Relapse of UC

  Over 6 Months

• Endoscopic Remission of UC With No or Mild Symptoms at 6 Months

  6 Months

• Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months

  Baseline and 6 months

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score

  6 Months

Study Arms (2)

SPD476

EXPERIMENTAL

Mesalazine

Drug: SPD476

Asacol

ACTIVE COMPARATOR

Drug: Asacol

Interventions

SPD476 DRUG

2.4 g/day Once Daily (QD)

Also known as: Lialda, mesalazine, mesalamine, MMX mesalamine

SPD476

Asacol DRUG

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

Also known as: mesalamine

Asacol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• proctitis
• previous resective colonic surgery
• Crohn's disease
• hypersensitivity to salicylates
• moderate/severe renal impairment

Sponsors & Collaborators

• Shire: lead

Study Sites (142)

Birmingham Gastroenterology Associates

Birmingham, Alabama, 35209, United States

Location

Connecticut Gastroenterology Institute

Bristol, Connecticut, 06010, United States

Location

Washington Gastroenterology

Washington D.C., District of Columbia, 20010, United States

Location

Southern Clinical Research Consultants

Hollywood, Florida, 33021, United States

Location

Boorland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Midwest Clinical Research Center

Moline, Illinois, 61265, United States

Location

Gastrointestinal Clinic of Quad Cities

Davenport, Iowa, 52807, United States

Location

Drug Research Services, Inc.

Metairie, Louisiana, 70006, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Center for Digestive and Liver Diseases, Inc

Mexico, Missouri, 65265, United States

Location

New York Center for Clinical Research

Lake Success, New York, 11042, United States

Location

ClinSearch

Chattanooga, Tennessee, 37404, United States

Location

S D Khan

Houston, Texas, 77090, United States

Location

Hospital Italiano de Buenos Aires

Capital Federal, Buenos Aires, C1181ACH, Argentina

Location

Centro Integral De Gastroenterologia

Ciudad de Buenos Aires, C1425EUG, Argentina

Location

Hospital Italiano de Mendoza, FINAMED SA

Mendoza, M5519GLU, Argentina

Location

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, 2200, Australia

Location

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Eastern Health Hospital

Box Hill, Victoria, 3128, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Imelda General Hospital

Bonheiden, 2820, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Heilig Hart ziekenhuis vzw Roeselare-Menen

Roeselare, 8800, Belgium

Location

Unigastro

Castelo, 13070-040, Brazil

Location

Hospital de Clinicas

Porto Alegre, Brazil

Location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941-290, Brazil

Location

Universidade Federal da Bahia - Hospital

Salvador, 40110-060, Brazil

Location

Hospital Sao Paulo

São Paulo, 01244-020, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, 05651-901, Brazil

Location

University of Calgary

Calgary, Alberta, T2N 4NI, Canada

Location

Toronto Digestive Disease Associates, Inc.

Toronto, Ontario, M3N2V7, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Hópital Hótel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

GI Research

Edmonton, T5H4B9, Canada

Location

Hospital del Salvador

Santiago, 7500922, Chile

Location

Clinica Las Condes

Santiago, 7591046, Chile

Location

Hospital Clinico P.UC

Santiago, 8330024, Chile

Location

Hospital San Juan de Dios

Santiago, 8350533, Chile

Location

Fakultni Nemocnice Plzen

Pilsen, 30460, Czechia

Location

NZZ Online 24 s.r.o

Prague, 120 00, Czechia

Location

Remedis s.r.o

Prague, 140 00, Czechia

Location

Thomavers Hospital

Prague, 14059, Czechia

Location

Klinicke Centrum ISCARE I.V.F

Prague, 170 04, Czechia

Location

Nemocnice Jablonec nad Nisou p.o

Prague, 466 60, Czechia

Location

Oblastni Nemocnice Pribram

Příbram, 261 26, Czechia

Location

Nemocnice Tabor A.S.

Tábor, 390 03, Czechia

Location

Masarykova Nemocnice

Ústí nad Labem, 401 13, Czechia

Location

Bispebjerg Hospital

Copenhagen NV, 1400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Koge University Hospital

Køge, 4600, Denmark

Location

CHU de Grenoble

Grenoble, France

Location

Hospital De L'Archet

Nice, France

Location

Hospital Haut Leveque

Pessac, France

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitat des Saarlandes

Homburg, Germany

Location

Gastroenterologische Praxis Prof. Hackelsberger

Wiesbaden, Germany

Location

Peterfy Sandor utcai

Budapest, H-1076, Hungary

Location

Semmelweis Egyetem

Budapest, H-1083, Hungary

Location

Debreceni Egyetem OEC - III

Debrecen, H-4012, Hungary

Location

Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

Eger, H-3300, Hungary

Location

Pandy Kalman County Hospital

Gyula, H-5700, Hungary

Location

Amrita Institute of Medical Sciences

Kochi, Kerala, 682 026, India

Location

Lifeline Multispeciality Hospital

Chennai, 600096, India

Location

Asian Institute of Gastreoenterology

Hyderabaad, 500082, India

Location

S.R. Kalla Memorial Gastro & General Hospital

Jaipur, 302001, India

Location

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, 226 014, India

Location

Dayanand Medical College and Hospital

Ludhiana, 141 001, India

Location

Jaslok Hospital and Research Centre

Mumbai, 400 026, India

Location

All India Institute of Medical Sciences

New Delhi, 110 029, India

Location

Sree Gokulam Medical Centre & Research Foundation

Trivandrum, 695607, India

Location

Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

La Paz, Baja California Sur, CP23000, Mexico

Location

Hospital San Javier

Guadalajara, 44670, Mexico

Location

Central de Especialidades Medicas (FIDEPAZ)

La Paz, 23090, Mexico

Location

Mexican Institute of Clinical Research

Mexico City, 6700, Mexico

Location

Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

Mexico City, CP 14000, Mexico

Location

Hospital Angeles Torreón

Torreón, 27250, Mexico

Location

Orbis Medical Centre

Sittard, 6162 BG, Netherlands

Location

Isala Clinics

Zwolle, 8025 AB, Netherlands

Location

Shakespeare Specialist Group

Auckland, 620, New Zealand

Location

Waikato DHB Hospital

Hamilton, 2001, New Zealand

Location

Tauranga Hospital BOP Medical

Tauranga, 3112, New Zealand

Location

Wellington Hospital

Wellington, 6242, New Zealand

Location

Hospital Nacional Edgardo Rebagliati Martins

Lima, Lima-11, Peru

Location

Hospital Nacional Guillermo Alemnara Irigoyen

Lima, Lima-13, Peru

Location

Clinica Anglo America

Lima, Lima-27, Peru

Location

Clinica El Golf

Lima, Lima-27, Peru

Location

Klinika Gastroenterologi

Bialystok, Poland

Location

Klinika Gastroenterologii

Lodz, Poland

Location

Klinika Gastroenterologii

Szczecin, Poland

Location

Miejska Przychodnia Specjalistyczna

Torun, Poland

Location

Katedra i Klinika Gastroenterologii

Warsaw, Poland

Location

Hospital Sao Marcos

Braga, 4701-965, Portugal

Location

Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital Geral Santo Antonio

Porto, 4099-001, Portugal

Location

Colentina Clinical Hospital

Bucharest, 020125, Romania

Location

Prf. Dr D. Gerota Emergency Hospital

Bucharest, 021392, Romania

Location

Octavian Fodor Clinical Emergency Hospital

Cluj-Napoca, 400162, Romania

Location

County Emergency Hospital

Constanța, 900591, Romania

Location

Institute of Gastronenterology & Hepatology

Iași, 700111, Romania

Location

Clinical County Emergency Hospital

Târgu Mureş, 540103, Romania

Location

City Hospital #24

Moscow, Russia

Location

City Hospital #51

Moscow, Russia

Location

Scientific Centre of Coloproctology

Moscow, Russia

Location

City Hospital #122

Saint Petersburg, Russia

Location

Russian Academy of Sciences

Saint Petersburg, Russia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Louis Leipoldt Medical Centre

Bellville, Western Cape, 7505, South Africa

Location

New Groote Schuur Hospital

Observatory, Western Cape, 7925, South Africa

Location

Kingsbury Hospital

Cape Town, 7708, South Africa

Location

St Augustine's Hospital

Durban, 4001, South Africa

Location

Parklands Medical Centre

Durban, 4091, South Africa

Location

Milpark Hospital

Johannesburg, 2193, South Africa

Location

Greenacres Hospital

Port Elizabeth, 6057, South Africa

Location

2H Arun Place

Somerset West, 7130, South Africa

Location

Hallyam University, Sacred Heart Hospital

Anyang-si, 431-070, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Samsung Medical Centre

Seoul, 135-710, South Korea

Location

The Catholic University of Korea Kangnam St Mary's Hospital

Seoul, 137-040, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Yonsei University, College of Medicine

Seoul, South Korea

Location

Hospital Universitario Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital de Sagunto

Valencia, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Sophiahemmet

Stockholm, 11486, Sweden

Location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

St. Mark's Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Addenbrookes Hospital Department of Gastroenterology

Cambridge, CB2 2QQ, United Kingdom

Location

Imperial College School of Medicine

London, W12 0NN, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Related Links

• FDA-approved label
• FDA recall information

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: April 8, 2005
• Primary Completion: September 7, 2009
• Study Completion: September 7, 2009
• Last Updated: June 14, 2021
• Results First Posted: September 21, 2010

Record last verified: 2021-06

Locations

AU (6); CA (5); CZ (9); DK (3); PL (5); BR (6); DE (3); ME (6); SG (3); PT (3); RU (5); KR (6); SE (4); TW (3); FR (3); GB (5); HU (5); IN (9); PE (4); RO (6); AR (3); BE (3); NL (2); NZ (4); ES (4); US (15); ZA (8); CL (4)