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Ulcerative ColitisPhase 4NCT00446849

Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

A Phase 4 study testing MMX Mesalamine in people with Ulcerative Colitis, run by Shire at 62 sites in United States.

Completed

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

Official record
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Trial summary

To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
62 sitesUnited States
Study dates
1 May 2007to 17 Aug 2009
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

  • Male and female subjects aged at least 18 years with active mild to moderate UC may enter the Acute Phase of the study.
  • Must have a previous diagnosis of UC confirmed by histology and endoscopy or radiology.
  • Males or non-pregnant, non-lactating FOCP who have a negative serum pregnancy test prior to entering the study and who are using adequate forms of contraception for the duration of the study.
  • General medical assessment must be satisfactory and there must not be clinically significant and relevant abnormalities.
  • Subject must have had >2 acute episodes of UC (a documented episode of increased bowel frequency with rectal blood loss for which UC therapy was intensified) in their medical history.
  • Subjects who have relapsed on maintenance therapy after 2 weeks with doses of mesalamine at: a. <2.0g/day, will be allowed into the Acute Phase at 2.4g/day QD, or b. between 2.0g/day - 3.0g/day will be allowed into the Acute Phase at 4.8g/day QD.
  • Subjects determined to be quiescent at study entry on prior oral mesalamine therapy will be eligible to enter directly into the Maintenance Phase.
  • UC must have been considered to be quiescent, with scores of zero for both rectal bleeding and bowel movements.

Who cannot join

  • Subjects who have been in relapse for >6 weeks.
  • Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening.
  • Subjects must not have used another investigational agent within the last 30 days prior to enrollment.
  • Subjects who have unsuccessfully treated their current relapse with steroids or a mesalamine dose of >2.0 g/day.
  • Subjects who have relapsed on maintenance therapy with doses of mesalamine >2.0g/day. If the subject had a recent dose reduction from 2.0g/day to less than or equal to 2.0g/day and relapsed within 2 weeks of that dose reduction, the subject will not be eligible.
  • Subjects who have used systemic or rectal steroids within the last 4 weeks prior to Baseline, immunosuppressants within the last 6 weeks, antibiotic use within the last 7 days or chronic use of any anti-inflammatory drugs within 7 days prior to Baseline.
Show all 20Show fewer
  • Subjects with hypersensitivity to salicylates/aspirin are excluded.
  • Subjects with moderate or severe hepatic impairment.
  • Subjects with Crohn's Disease, proctitis (where the extent of inflammation is less than or equal to 15cm), short bowel syndrome, bleeding disorders, or active peptic ulcer disease.
  • Subjects with asthma are excluded only if they are known to be mesalamine-sensitive.
  • Subjects with a positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter) are excluded, as are those with C. difficile toxin present or with ova or parasites as detected by microscopy.
  • Subjects who have a history of previous colonic surgery.
  • Subjects with moderate or severe renal impairment are contra-indicated for treatment with mesalamine compounds and are excluded from the study.
  • Subjects with current or recurrent disease that could affect the colon, the action, absorption or disposition of the study drug, or clinical or laboratory assessments.
  • Subjects with current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the study drug or procedures.
  • Subjects with a history of alcohol or other substance abuse within the previous year.
  • Subjects who withdrew from a mesalamine trial due to a possibly or probably related severe AE or SAE are not eligible to enter this study.
  • Exclusion Criteria - Maintenance Phase (in addition to above inclusion for the Acute Phase):
  • Subjects who have withdrawn from the Acute Phase before study visit A3.
  • Subjects with severe UC according to the PGA.

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

United States62 sites

  • Digestive Disorders Associates Research Division

    Annapolis, Maryland, 21401

  • Maryland Clinical Trials

    Annapolis, Maryland, 21401

  • Western Suffolk Gastroenterology Associates, LLP

    Bay Shore, New York, 11706

  • Gastroenterology Associates

    Beachwood, Ohio, 44122

  • Birmingham Gastroenterology Assoc.

    Birmingham, Alabama, 35209

  • Clinical Research Group of Montana, PLLC

    Bozeman, Montana, 59718

  • ClinSearch

    Chattanooga, Tennessee, 37404

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • New River Valley Research

    Christiansburg, Virginia, 24073

  • Consultants for Clinical Research, Inc.

    Cincinnati, Ohio, 45219

  • Digestive Health Network

    Cincinnati, Ohio, 45220

  • Gastro Consultants of Greater Cincinnati

    Cincinnati, Ohio, 45242

  • Advanced Digestive Care, PA

    Clearwater, Florida, 33756

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Gild Consultants, P.C.

    Dayton, Ohio, 45415

  • Soapstone Ctr. for Clin. Rsrch

    Decatur, Georgia, 30034

  • South Denver Gastroenterology, P.C.

    Englewood, Colorado, 80113

  • Gastroenterology of Midsouth

    Germantown, Tennessee, 38138

  • The Center for GI Medicine of Fairfield & Westchester, P.C.

    Greenwich, Connecticut, 06830

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Southern Clinical Research Consultants

    Hollywood, Florida, 33021

  • Houston Endoscopy & Research Center

    Houston, Texas, 77024

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Maryland Digestive Disease Research, LLC

    Laurel, Maryland, 20707

  • VA Medical Center - Long Beach

    Long Beach, California, 90822

  • Long Island Clinical Research Associates, LLP

    Long Island City, New York, 11021

  • Gastroenterology Assoc./Cen.GA

    Macon, Georgia, 31201

  • Marlboro Gastroenterology

    Manalapan, New Jersey, 07726

  • North Shore University Hospital

    Manhasset, New York, 11030

  • NW GA Gastroenterology

    Marietta, Georgia, 30060

  • Center for Digestive and Liver Diseases

    Mexico, Missouri, 65265

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Midwest Clinical Research Associates

    Moline, Illinois, 61265

  • Connecticut Gastroenterology Associates

    New Haven, Connecticut, 06510

  • Digestive Medicine of Long Island

    New Hyde Park, New York, 11042

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Mount Sinai and Metropolitan Hospital

    New York, New York, 10128

  • Central Sooner Research

    Norman, Oklahoma, 73069

  • GI Associates

    Overland Park, Kansas, 66212

  • Advanced Gastroenterology Associates

    Palm Harbor, Florida, 34684

  • Accelovance

    Peoria, Illinois, 61602

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Rockford Gastroenterology Associates

    Rockford, Illinois, 61107

  • Gastroenterology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Sharp Rees-Stealy Medical Group

    San Diego, California, 92101

  • Clinical Applications Laboratories, Inc.

    San Diego, California, 92103

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Inland Empire Gastroenterology, P.S.

    Spokane, Washington, 99204

  • Spokane Digestive Disease Center, P.S.

    Spokane, Washington, 99204

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Upstate Gastroentrology Associates

    Troy, New York, 12180

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

  • Aurora Health Center- Waukesha

    Waukesha, Wisconsin, 53186

Other trials in United States

About this study

Official title: A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)

To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

Being tested
MMX Mesalamine
Keywords
ulcerative colitis, compliance, mesalamine, clinical study, clinical trial, clinical research, maintenance, long term, uc study, uc trial, uc research, open label, once a day, once, daily, daily dosing, simple, oral
Medical subject headings
Colitis, Ulcerative, Patient Compliance, Charcot-Marie-Tooth disease, Type 1C

What participants receive

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

  • MMX MesalamineDrug

    Also called Lialda

    MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).

Study groups in NCT00446849
Study groupRoleWhat they receive
MMX MesalamineExperimentalNot described
Receives: Drug: MMX Mesalamine

What is being measured

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

  1. Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months

    Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.

    Measured: 6 months

Secondary outcomes (5)

  1. Clinical Recurrence of UC During the Maintenance Phase at 12 Months

    Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.

    Measured: 12 Months

  2. Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months

    Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100.

    Measured: 6 Months

  3. Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months

    Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100.

    Measured: 12 months

  4. Quiescent UC During the Maintenance Phase at 12 Months

    Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are 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

  5. Endoscopic Remission of UC During the Maintenance Phase at 12 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: 12 Months

Timeline

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

  1. First posted13 Mar 2007 (estimated)
  2. Study start1 May 2007
  3. Primary completion17 Aug 2009
  4. Study completion17 Aug 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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00446849
Sponsor's protocol ID
SPD476-404
Status last verified
Jun 2021
First submitted
12 Mar 2007
Last updated
14 Jun 2021

Publications

  • Kane S, Katz S, Jamal MM, Safdi M, Dolin B, Solomon D, Palmen M, Barrett K. Strategies in maintenance for patients receiving long-term therapy (SIMPLE): a study of MMX mesalamine for the long-term maintenance of quiescent ulcerative colitis. Inflamm Bowel Dis. 2012 Jun;18(6):1026-33. doi: 10.1002/ibd.21841. Epub 2011 Aug 11.

    PubMed 21837775

  • Yarlas A, Yen L, Hodgkins P. The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX (R) formulated delayed-release mesalamine. Qual Life Res. 2015 Mar;24(3):671-83. doi: 10.1007/s11136-014-0797-2. Epub 2014 Sep 6.

    PubMed 25193617

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MMX Mesalamine in people with Ulcerative Colitis, run by Shire at 62 sites in United States.

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 8 inclusion and 20 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 62 sites in United States. 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 8 Jul 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?

Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase 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 NCT00446849, which also lists 2 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 14 Jun 2021.

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