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Ulcerative ColitisPhase 3NCT00151892

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

A Phase 3 study testing SPD476 and Asacol in people with Ulcerative Colitis, run by Shire at 142 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
SPD476 and Asacol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
829 participants
Where
142 sitesin 28 countries
Study dates
8 Apr 2005to 7 Sep 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

142 sites in 28 countries.

142 sites in 28 countries

United States15 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • ClinSearch

    Chattanooga, Tennessee, 37404

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Southern Clinical Research Consultants

    Hollywood, Florida, 33021

  • S D Khan

    Houston, Texas, 77090

  • Boorland-Groover Clinic

    Jacksonville, Florida, 32256

  • New York Center for Clinical Research

    Lake Success, New York, 11042

  • Drug Research Services, Inc.

    Metairie, Louisiana, 70006

  • Center for Digestive and Liver Diseases, Inc

    Mexico, Missouri, 65265

  • Midwest Clinical Research Center

    Moline, Illinois, 61265

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington Gastroenterology

    Washington D.C., District of Columbia, 20010

Other trials in United States

Czechia9 sites

  • Fakultni Nemocnice Plzen

    Pilsen, 30460

  • NZZ Online 24 s.r.o

    Prague, 120 00

  • Remedis s.r.o

    Prague, 140 00

  • Thomavers Hospital

    Prague, 14059

  • Klinicke Centrum ISCARE I.V.F

    Prague, 170 04

  • Nemocnice Jablonec nad Nisou p.o

    Prague, 466 60

  • Oblastni Nemocnice Pribram

    Příbram, 261 26

  • Nemocnice Tabor A.S.

    Tábor, 390 03

  • Masarykova Nemocnice

    Ústí nad Labem, 401 13

Other trials in Czechia

India9 sites

  • Lifeline Multispeciality Hospital

    Chennai, 600096

  • Asian Institute of Gastreoenterology

    Hyderabaad, 500082

  • S.R. Kalla Memorial Gastro & General Hospital

    Jaipur, 302001

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682 026

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226 014

  • Dayanand Medical College and Hospital

    Ludhiana, 141 001

  • Jaslok Hospital and Research Centre

    Mumbai, 400 026

  • All India Institute of Medical Sciences

    New Delhi, 110 029

  • Sree Gokulam Medical Centre & Research Foundation

    Trivandrum, 695607

Other trials in India

South Africa8 sites

  • Louis Leipoldt Medical Centre

    Bellville, Western Cape, 7505

  • Kingsbury Hospital

    Cape Town, 7708

  • St Augustine's Hospital

    Durban, 4001

  • Parklands Medical Centre

    Durban, 4091

  • Milpark Hospital

    Johannesburg, 2193

  • New Groote Schuur Hospital

    Observatory, Western Cape, 7925

  • Greenacres Hospital

    Port Elizabeth, 6057

  • 2H Arun Place

    Somerset West, 7130

Other trials in South Africa

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Eastern Health Hospital

    Box Hill, Victoria, 3128

  • Concord Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

Other trials in Australia

Brazil6 sites

  • Unigastro

    Castelo, 13070-040

  • Hospital de Clinicas

    Porto Alegre

  • Universidade Federal do Rio de Janeiro

    Rio de Janeiro, 21941-290

  • Universidade Federal da Bahia - Hospital

    Salvador, 40110-060

  • Hospital Sao Paulo

    São Paulo, 01244-020

  • Hospital Israelita Albert Einstein

    São Paulo, 05651-901

Other trials in Brazil

Mexico6 sites

  • Hospital San Javier

    Guadalajara, 44670

  • Unidad Medica de Endoscopia y Cirugia (UNIMEDEC)

    La Paz, Baja California Sur, CP23000

  • Central de Especialidades Medicas (FIDEPAZ)

    La Paz, 23090

  • Mexican Institute of Clinical Research

    Mexico City, 6700

  • Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán

    Mexico City, CP 14000

  • Hospital Angeles Torreón

    Torreón, 27250

Other trials in Mexico

Romania6 sites

  • Colentina Clinical Hospital

    Bucharest, 020125

  • Prf. Dr D. Gerota Emergency Hospital

    Bucharest, 021392

  • Octavian Fodor Clinical Emergency Hospital

    Cluj-Napoca, 400162

  • County Emergency Hospital

    Constanța, 900591

  • Institute of Gastronenterology & Hepatology

    Iași, 700111

  • Clinical County Emergency Hospital

    Târgu Mureş, 540103

Other trials in Romania

South Korea6 sites

  • Hallyam University, Sacred Heart Hospital

    Anyang-si, 431-070

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Centre

    Seoul, 135-710

  • The Catholic University of Korea Kangnam St Mary's Hospital

    Seoul, 137-040

  • Asan Medical Center

    Seoul

  • Yonsei University, College of Medicine

    Seoul

Other trials in South Korea

Canada5 sites

  • University of Calgary

    Calgary, Alberta, T2N 4NI

  • GI Research

    Edmonton, T5H4B9

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T2M4

  • Hópital Hótel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Toronto Digestive Disease Associates, Inc.

    Toronto, Ontario, M3N2V7

Other trials in Canada

Hungary5 sites

  • Peterfy Sandor utcai

    Budapest, H-1076

  • Semmelweis Egyetem

    Budapest, H-1083

  • Debreceni Egyetem OEC - III

    Debrecen, H-4012

  • Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia

    Eger, H-3300

  • Pandy Kalman County Hospital

    Gyula, H-5700

Other trials in Hungary

Poland5 sites

  • Klinika Gastroenterologi

    Bialystok

  • Klinika Gastroenterologii

    Lodz

  • Klinika Gastroenterologii

    Szczecin

  • Miejska Przychodnia Specjalistyczna

    Torun

  • Katedra i Klinika Gastroenterologii

    Warsaw

Other trials in Poland

Russia5 sites

  • City Hospital #24

    Moscow

  • City Hospital #51

    Moscow

  • Scientific Centre of Coloproctology

    Moscow

  • City Hospital #122

    Saint Petersburg

  • Russian Academy of Sciences

    Saint Petersburg

Other trials in Russia

United Kingdom5 sites

  • Addenbrookes Hospital Department of Gastroenterology

    Cambridge, CB2 2QQ

  • St. Mark's Hospital

    Harrow, Middlesex, HA1 3UJ

  • Imperial College School of Medicine

    London, W12 0NN

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Chile4 sites

  • Hospital del Salvador

    Santiago, 7500922

  • Clinica Las Condes

    Santiago, 7591046

  • Hospital Clinico P.UC

    Santiago, 8330024

  • Hospital San Juan de Dios

    Santiago, 8350533

Other trials in Chile

New Zealand4 sites

  • Shakespeare Specialist Group

    Auckland, 620

  • Waikato DHB Hospital

    Hamilton, 2001

  • Tauranga Hospital BOP Medical

    Tauranga, 3112

  • Wellington Hospital

    Wellington, 6242

Other trials in New Zealand

Peru4 sites

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, Lima-11

  • Hospital Nacional Guillermo Alemnara Irigoyen

    Lima, Lima-13

  • Clinica Anglo America

    Lima, Lima-27

  • Clinica El Golf

    Lima, Lima-27

Other trials in Peru

Spain4 sites

  • Hospital Universitario Germans Trias I Pujol

    Badalona, 08916

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital de Sagunto

    Valencia

Other trials in Spain

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Sophiahemmet

    Stockholm, 11486

  • Karolinska University Hospital

    Stockholm, 14186

  • Karolinska University Hospital

    Stockholm, 17176

Other trials in Sweden

Argentina3 sites

  • Hospital Italiano de Buenos Aires

    Capital Federal, Buenos Aires, C1181ACH

  • Centro Integral De Gastroenterologia

    Ciudad de Buenos Aires, C1425EUG

  • Hospital Italiano de Mendoza, FINAMED SA

    Mendoza, M5519GLU

Other trials in Argentina

Belgium3 sites

  • Imelda General Hospital

    Bonheiden, 2820

  • Ziekenhuis Oost Limburg

    Genk, 3600

  • Heilig Hart ziekenhuis vzw Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

Denmark3 sites

  • Bispebjerg Hospital

    Copenhagen NV, 1400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Koge University Hospital

    Køge, 4600

Other trials in Denmark

France3 sites

  • CHU de Grenoble

    Grenoble

  • Hospital De L'Archet

    Nice

  • Hospital Haut Leveque

    Pessac

Other trials in France

Germany3 sites

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau

  • Universitat des Saarlandes

    Homburg

  • Gastroenterologische Praxis Prof. Hackelsberger

    Wiesbaden

Other trials in Germany

Portugal3 sites

  • Hospital Sao Marcos

    Braga, 4701-965

  • Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital Geral Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Singapore3 sites

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Taiwan3 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Netherlands2 sites

  • Orbis Medical Centre

    Sittard, 6162 BG

  • Isala Clinics

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

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

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.

Being tested
SPD476, Asacol
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPD476Drug

    Also called Lialda, mesalazine, mesalamine, MMX mesalamine

    2.4 g/day Once Daily (QD)

  • AsacolDrug

    Also called mesalamine

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

Study groups in NCT00151892
Study groupRoleWhat they receive
SPD476ExperimentalMesalazine
Receives: Drug: SPD476
AsacolActive comparatorNot described
Receives: Drug: Asacol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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].

    Measured: 6 Months

Secondary outcomes (4)

  1. Withdrawal Due to Relapse of UC

    Relapse is defined as withdrawal from the study due to lack of efficacy.

    Measured: Over 6 Months

  2. 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).

    Measured: 6 Months

  3. 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.

    Measured: Baseline and 6 months

  4. 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.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2005 (estimated)
  2. Study start8 Apr 2005
  3. Primary completion7 Sep 2009
  4. Study completion7 Sep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
829 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00151892
Sponsor's protocol ID
SPD476-304
Other IDs
2004-004184-29, 2004
Status last verified
Jun 2021
First submitted
7 Sep 2005
Last updated
14 Jun 2021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPD476 and Asacol in people with Ulcerative Colitis, run by Shire at 142 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Czechia, India, South Africa, Australia and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00151892.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.

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