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)

NCT00446849 | Completed Phase 4 Results

• 1 other identifier: SPD476-404
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 62

Brief Summary

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

Conditions

Ulcerative Colitis

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

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• Clinical Recurrence of UC During the Maintenance Phase at 12 Months

  12 Months

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

  6 Months

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

  12 months

• Quiescent UC During the Maintenance Phase at 12 Months

  12 Months

• Endoscopic Remission of UC During the Maintenance Phase at 12 Months

  12 Months

Study Arms (1)

MMX Mesalamine

EXPERIMENTAL

Drug: MMX Mesalamine

Interventions

MMX Mesalamine DRUG

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

Also known as: Lialda

MMX Mesalamine

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (62)

Birmingham Gastroenterology Assoc.

Birmingham, Alabama, 35209, United States

Location

Clopton Clinic

Jonesboro, Arkansas, 72401, United States

Location

VA Medical Center - Long Beach

Long Beach, California, 90822, United States

Location

Sharp Rees-Stealy Medical Group

San Diego, California, 92101, United States

Location

Clinical Applications Laboratories, Inc.

San Diego, California, 92103, United States

Location

South Denver Gastroenterology, P.C.

Englewood, Colorado, 80113, United States

Location

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

Greenwich, Connecticut, 06830, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Connecticut Gastroenterology Associates

New Haven, Connecticut, 06510, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Advanced Digestive Care, PA

Clearwater, Florida, 33756, United States

Location

Southern Clinical Research Consultants

Hollywood, Florida, 33021, United States

Location

Borland-Groover Clinic

Jacksonville, Florida, 32256, United States

Location

United Medical Research

New Smyrna Beach, Florida, 32168, United States

Location

Advanced Gastroenterology Associates

Palm Harbor, Florida, 34684, United States

Location

Soapstone Ctr. for Clin. Rsrch

Decatur, Georgia, 30034, United States

Location

Gastroenterology Assoc./Cen.GA

Macon, Georgia, 31201, United States

Location

NW GA Gastroenterology

Marietta, Georgia, 30060, United States

Location

Midwest Clinical Research Associates

Moline, Illinois, 61265, United States

Location

Accelovance

Peoria, Illinois, 61602, United States

Location

Rockford Gastroenterology Associates

Rockford, Illinois, 61107, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Gastrointestinal Clinic of Quad Cities

Davenport, Iowa, 52807, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

GI Associates

Overland Park, Kansas, 66212, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71103, United States

Location

Digestive Disorders Associates Research Division

Annapolis, Maryland, 21401, United States

Location

Maryland Clinical Trials

Annapolis, Maryland, 21401, United States

Location

Maryland Digestive Disease Research, LLC

Laurel, Maryland, 20707, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Center for Digestive and Liver Diseases

Mexico, Missouri, 65265, United States

Location

Clinical Research Group of Montana, PLLC

Bozeman, Montana, 59718, United States

Location

Marlboro Gastroenterology

Manalapan, New Jersey, 07726, United States

Location

Western Suffolk Gastroenterology Associates, LLP

Bay Shore, New York, 11706, United States

Location

Long Island Clinical Research Associates, LLP

Long Island City, New York, 11021, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Digestive Medicine of Long Island

New Hyde Park, New York, 11042, United States

Location

Mount Sinai and Metropolitan Hospital

New York, New York, 10128, United States

Location

Upstate Gastroentrology Associates

Troy, New York, 12180, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

East Carolina Gastroenterology

Jacksonville, North Carolina, 28546, United States

Location

Gastroenterology Associates

Beachwood, Ohio, 44122, United States

Location

Consultants for Clinical Research, Inc.

Cincinnati, Ohio, 45219, United States

Location

Digestive Health Network

Cincinnati, Ohio, 45220, United States

Location

Gastro Consultants of Greater Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Gild Consultants, P.C.

Dayton, Ohio, 45415, United States

Location

Central Sooner Research

Norman, Oklahoma, 73069, United States

Location

Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

ClinSearch

Chattanooga, Tennessee, 37404, United States

Location

Gastroenterology of Midsouth

Germantown, Tennessee, 38138, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Houston Endoscopy & Research Center

Houston, Texas, 77024, United States

Location

Gastroenterology Clinic of San Antonio

San Antonio, Texas, 78229, United States

Location

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States

Location

New River Valley Research

Christiansburg, Virginia, 24073, United States

Location

Inland Empire Gastroenterology, P.S.

Spokane, Washington, 99204, United States

Location

Spokane Digestive Disease Center, P.S.

Spokane, Washington, 99204, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Aurora Health Center- Waukesha

Waukesha, Wisconsin, 53186, United States

Location

Related Publications (2)

• 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.

  PMID: 21837775 RESULT

• 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.

  PMID: 25193617 DERIVED

Related Links

• FDA recall information
• FDA-approved label

MeSH Terms

Conditions

Colitis, Ulcerative; Patient Compliance; Charcot-Marie-Tooth disease, Type 1C

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: May 1, 2007
• Primary Completion: August 17, 2009
• Study Completion: August 17, 2009
• Last Updated: June 14, 2021
• Results First Posted: July 8, 2010

Record last verified: 2021-06

Locations

US (62)