AzTrials
AzTrials

Ulcerative ColitisPhase 4NCT01124149

Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

A Phase 4 study testing MMX mesalamine/ mesalazine in people with Ulcerative Colitis, run by Shire at 105 sites in 15 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

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX… 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?
MMX mesalamine/ mesalazine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
105 sitesin 15 countries
Study dates
29 Jun 2010to 7 Dec 2012
Phase
Phase 4
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

  • Adults aged 18 or older
  • Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
  • Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
  • Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.

Who cannot join

  • Severe UC
  • Acute flare with onset greater than >6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.
  • Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
  • Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day
  • Acute flare on a 5-ASA maintenance therapy of >3.2 g/day
  • Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
Show all 9Show fewer
  • History of biologic (anti-TNF agent) use
  • Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted
  • Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments

Trial locations and contacts

105 sites in 15 countries.

105 sites in 15 countries

United States34 sites

  • Alexandria Clinical Research

    Alexandria, Virginia, 22304

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Digestive Disorders Associates

    Annapolis, Maryland, 21401

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30342

  • Digestive Disease Associates

    Baltimore, Maryland, 21229

  • Birmingham Gastroenterology Associates, PC

    Birmingham, Alabama, 35209

  • Conneticut Gastroenterolgy Institute

    Bristol, Connecticut, 06010

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Ohio Gastroenterolgy and Liver Intstitute

    Cincinnati, Ohio, 45219

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Digestive & Liver Disease Specialists

    Garden Grove, California, 92840

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • LeBauer Research Associates

    Greensboro, North Carolina, 27402

  • S.D. Khan

    Houston, Texas, 77090

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Gastroenterology Associates, LLC

    Kingsport, Tennessee, 37660

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Long Beach VA Medical Center

    Long Beach, California, 90822

  • Atlanta Gastroenterology Associates

    Marietta, Georgia, 30067

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Center for Digestive & Liver Disease, Inc.

    Mexico, Missouri, 65265

  • Wisconsin Center for Advances Research

    Milwaukee, Wisconsin, 53215

  • Midwest Clinical Research Associates

    Moline, Illinois, 61265

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Advances Gastroenterology Associates

    Palm Harbor, Florida, 34684

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Gastroenterology Clinic of San Antonio, PA

    San Antonio, Texas, 78229

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • Colon and Rectal Disease Center

    Sandy City, Utah, 84070

  • Physicians Research Option, LLC

    Sandy City, Utah, 84094

  • Gastrointestinal Research Associates

    Setauket, New York, 11733

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Center for Digestive Health

    Troy, Michigan, 48098

Other trials in United States

India13 sites

  • Mehta Hospital

    Ahmedabad, Gujarat, 380006

  • Institute of Digestive & Liver Diseases

    Guwahati, Assam, 781006

  • Asian Institute of Gastroenterology

    Hyderabad, Andhra Pradesh, 500082

  • S R Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001

  • Dr. Nijhawan Clinic

    Jaipur, Rajasthan, 302017

  • Chhatrapati Shahuji Maharaj Medical University

    Lucknow, Uttar Pradesh, 226003

  • Dayanand Medical College and hospital

    Ludhiana, Punjab, 141001

  • Kasturba Medical College Hospital

    Mangalore, Kamataka, 575001

  • Gastroenterology & Endoscopy Centre

    Nagpur, Maharashtra, 440 012

  • Sahyandri Speciality Hospital

    Pune, Maharashtra, 411004

  • Poona Hospital & Research Centre

    Pune, Maharashtra, 411030

  • Sree Gokulam Medical College and Research Foundation

    Thiruvananthapuram, Kerala, 695607

  • Manikya Institute of Gastroenterology & Hepatology

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Czechia10 sites

  • Private Gastroenterology centre

    České Budějovice, 37001

  • Derma Plus s.r.o. Gastroenterology

    České Budějovice, 390 01

  • Hepato-Gastroenterology HK s.r.o.

    Hradec Králové, 50012

  • Nemocnice Jablonec nad Nisou

    Jablonec nad Nisou, 46660

  • Faculty hospital Plzen- Lochotin

    Pilsen, 30460

  • IKEM (Institute klinicke a experimentalni mediciny)

    Prague, 14021

  • Klinicke Centrum ISCARE I.V.F.

    Prague, 17004

  • Nemocnice Tabor a.s.

    Tábor, 39003

  • Massarykova Nemocnice-Masaryk Hospital

    Ústí nad Labem, 40113

  • Orlickoustecka nemocnice a.s. (Hospital)

    Ústí nad Orlicí, 56218

Other trials in Czechia

Poland7 sites

  • NZOZ Centrum Medyczne Szpital Sw. Rodziny

    Lodz, 90-302

  • NZOZ Centrum Medyczne HCP

    Poznan, 61-485

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii

    Torun, 80-100

  • Nzoz Vivamed

    Warsaw, 03-580

  • LexMedica

    Wroclaw, 50-023

  • EMC Instytut Medyczny SA

    Wroclaw, 54-144

Other trials in Poland

South Africa7 sites

  • Rose Park Hospital Boanerges CC Trials

    Bloemfontein, Free State, 9301

  • Panorama Medi-Clinic

    Cape Town, Western Cape, 7500

  • Louis Leipoldt Medical Centre

    Cape Town, Western Cape, 7530

  • Kingsbury Hospital

    Cape Town, Western Cape, 7708

  • St. Augustine's Hospital

    Durban, KwaZulu-Natal, 4001

  • Parklands Medical Centre

    Durban, KwaZulu-Natal, 4091

  • Greenacres Hospital

    Port Elizabeth, 6057

Other trials in South Africa

Romania6 sites

  • Clinical Hospital "Dr. I. Cantacuzino"

    Bucharest, 020475

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Emergency University Clinical Hospital Bucuresti

    Bucharest, 050098

  • CMI de Gastroenterologie

    Târgu Mureş, Mureș County, 540461

  • Policlinic Algomed SRL

    Timișoara, 300002

  • Policlinica "Dr. Citu" SRL

    Timișoara, 300593

Other trials in Romania

Canada5 sites

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • CHAUQ- Hopital du Saint-Sacrement

    Québec, Quebec, G1S 4L8

  • Alpha Recherche Clinique

    Québec, Quebec, G2B 5S1

  • Toronto Digestive Disease Associates, Inc.

    Toronto, Ontario, M3N 2V7

Other trials in Canada

Hungary5 sites

  • Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika

    Debrecen, H-4032

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

    Gyula, 5700

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat

    Miskolc, H-3526

  • Karolina Korhaz, Belgyogyaszat es Gasztroenterologia

    Mosonmagyaróvár, 9200

  • Javorszky Odon Varosi Korhaz, Gasztroenterologia

    Vác, H-2600

Other trials in Hungary

Colombia4 sites

  • Ugasend S.A.

    Barranquilla, Atlántico

  • FOQUS, Centro de Investigacion Clinica

    Bogota, Cundinamarca

  • Hospital pablo Tobon uribe

    Medellín, Antioquia

  • Promotora medica las Americas S.A.

    Medellín, Antioquia

Other trials in Colombia

Belgium3 sites

  • Imelda General Hospital

    Bonheiden, 2820

  • vzw AZ Groeninge

    Kortrijk, 8500

  • Heilig Hart ziekenhuis vzw Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

France3 sites

  • Hopital Saint Andre

    Bordeaux, 33075

  • CHU Estaing

    Clermont-Ferrand, 63003

  • CHU Nantes- Hotel Dieu

    Nantes, 44000

Other trials in France

Ireland3 sites

  • Adelaide and Meath Hospital

    Dublin, 24

  • St Vincents' University Hospital

    Dublin, 4

  • Beaumont Hospital

    Dublin, 9

Other trials in Ireland

Germany2 sites

  • Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie

    Hanover, 30625

  • Stawdtisches Klinikum Lueneburg Gastroenterologie

    Lüneburg, 21339

Other trials in Germany

United Kingdom2 sites

  • St Mark's Hospital

    Harrow, Middlesex, HA1 3UJ

  • John Radcliffe Hospital

    Headington, Oxfordshire, OX3 9DU

Other trials in United Kingdom

Spain1 site

  • Hospital Universitario La Princesa

    Madrid, 28006

Other trials in Spain

About this study

Official title: A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

Being tested
MMX mesalamine/ mesalazine
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • MMX mesalamine/ mesalazineDrug

    Also called Lialda, Mezavant, Mezavant XL, Mezavant LP

    4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months

Study groups in NCT01124149
Study groupRoleWhat they receive
MMX mesalamine/ mesalazineExperimentalNot described
Receives: Drug: MMX mesalamine/ mesalazine

What is being measured

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

  1. Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase

    Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI 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. 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: 12 months

Secondary outcomes (7)

  1. Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase

    Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. 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: 12 months

  2. Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase

    Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.

    Measured: 12 months

  3. Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase

    Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).

    Measured: 12 months

  4. Improvement in Rectal Bleeding Score During the Acute Phase

    Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).

    Measured: 3 and 8 weeks

  5. Improvement in Stool Frequency Symptoms During the Acute Phase

    Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. 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: 3 and 8 weeks

  6. Percentage of Subjects in Complete Remission at Week 8 of Acute Phase

    Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI 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. 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: 8 Weeks

  7. Percentage of Subjects in Partial Remission at Week 8 of Acute Phase

    Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. The modified UC-DAI 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. 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: 8 weeks

Timeline

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

  1. First posted14 May 2010 (estimated)
  2. Study start29 Jun 2010
  3. Primary completion7 Dec 2012
  4. Study completion7 Dec 2012

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124149
Sponsor's protocol ID
SPD476-409
Other IDs
2009-017044-13, 2009
Status last verified
May 2021
First submitted
13 May 2010
Last updated
9 Jun 2021
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.

    PubMed 32801008

  • Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.

    PubMed 30294708

  • Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.

    PubMed 29361097

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MMX mesalamine/ mesalazine in people with Ulcerative Colitis, run by Shire at 105 sites in 15 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 4 inclusion and 9 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 9 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 105 sites in United States, India, Czechia, Poland, South Africa and 10 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Dec 2013). 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?

Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase (time frame: 12 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 NCT01124149, which also lists 3 linked publications.

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 9 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in