A Comparison of Once a Day Dose Compared to 2 Doses/Day

A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis

The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Mesalamine Once-Daily; Drug: Mesalamine Twice-Daily

Detailed Description

Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.

• Study Type: Interventional
• Enrollment (Actual): 1027
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1L 3L5
    • Research Facility
  • Quebec, Canada, G1S 4L8
    • Research Facility
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 3N5
      • Research Facility
  • Ontario
    • Guelph, Ontario, Canada, N1H 3R3
      • Research Facility
    • Hamilton, Ontario, Canada, L8N 4A6
      • Research Facility
    • Ottawa, Ontario, Canada, K1H 8L6
      • Research Facility
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Facility
    • Toronto, Ontario, Canada, M5G 2O4
      • Research Facility
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Facility
    • Montreal, Quebec, Canada, H3T 1E2
      • Research Facility
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Research Facility
  • San Juan, Puerto Rico, 00936
    • Research Facility
• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • Research Facility
    • Birmingham, Alabama, United States, 35209
      • Research Facility
    • Birmingham, Alabama, United States, 35294
      • Research Facility
    • Dothan, Alabama, United States, 26305-1156
      • Research Facility
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Research Facility
    • Scottsdale, Arizona, United States, 85259
      • Research Facility
    • Tucson, Arizona, United States, 85712
      • Research Facility
    • Tuscon, Arizona, United States, 85711
      • Research Facility
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Facility
    • Lowell, Arkansas, United States, 72745
      • Research Facility
  • California
    • Anaheim, California, United States, 92801
      • Research Facility
    • Beverly Hills, California, United States, 90210
      • Research Facility
    • Chico, California, United States, 95926
      • Research Facility
    • Encinitas, California, United States, 92024
      • Research Facility
    • Folsum, California, United States, 95630
      • Research Facility
    • La Mesa, California, United States, 91941
      • Research Facility
    • Lancaster, California, United States, 93534
      • Research Facility
    • Long Beach, California, United States, 90806
      • Research Facility
    • Los Angeles, California, United States, 90015
      • Research Facility
    • Los Angeles, California, United States, 90045
      • Research Facility
    • Madera, California, United States, 93637
      • Research Facility
    • Merced, California, United States, 95340
      • Research Facility
    • Mission Hills, California, United States, 91345
      • Research Facility
    • Monterey, California, United States, 93940
      • Research Facility
    • Murrieta, California, United States, 92562
      • Research Facility
    • Oakland, California, United States, 94609
      • Research Facility
    • Orange, California, United States, 92868
      • Research Facility
    • Palm Springs, California, United States, 92262
      • Research Facility
    • San Carlos, California, United States, 94070
      • Research Facility
    • San Diego, California, United States, 92123
      • Research Facility
    • San Diego, California, United States, 92103
      • Research Facility
    • San Diego, California, United States, 92117
      • Research Facility
    • San Francisco, California, United States, 94117
      • Research Facility
    • San Francisco, California, United States, 94122
      • Research Facility
    • Torrance, California, United States, 90503
      • Research Facility
    • Torrance, California, United States, 90505
      • Research Facility
    • Upland, California, United States, 91786
      • Research Facility
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Research Facility
    • Golden, Colorado, United States, 80401
      • Research Facility
    • Lafayette, Colorado, United States, 80026
      • Research Facility
    • Pueblo, Colorado, United States, 81008
      • Research Facility
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Research Facility
    • Meriden, Connecticut, United States, 06451
      • Research Facility
    • New Haven, Connecticut, United States, 06510
      • Research Facility
    • Norwalk, Connecticut, United States, 06851
      • Research Facility
    • Torrington, Connecticut, United States, 06790
      • Research Facility
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Research Facility
  • Florida
    • Aventura, Florida, United States, 33180
      • Research Facility
    • Fort Lauderdale, Florida, United States, 33308
      • Research Facility
    • Gainesville, Florida, United States, 32607
      • Research Facility
    • Hollywood, Florida, United States, 33021
      • Research Facility
    • Jacksonville, Florida, United States, 32207
      • Research Facility
    • Jacksonville, Florida, United States, 32223
      • Research Facility
    • Largo, Florida, United States, 33777
      • Research Facility
    • Maitland, Florida, United States, 32751
      • Research Facility
    • Naples, Florida, United States, 34102
      • Research Facility
    • New Port Richey, Florida, United States, 34652
      • Research Facility
    • North Miami Beach, Florida, United States, 33162
      • Research Facility
    • Orlando, Florida, United States, 32806
      • Research Facility
    • Palm Harbor, Florida, United States, 34684
      • Research Facility
    • Port Orange, Florida, United States, 32129
      • Research Facility
    • St Petersburg, Florida, United States, 33711
      • Research Facility
    • St. Petersburg, Florida, United States, 33707
      • Research Facility
    • Tallahassee, Florida, United States, 32308
      • Research Facility
    • Tampa, Florida, United States, 33613
      • Research Facility
    • Tampa, Florida, United States, 33607
      • Research Facility
    • Trinity, Florida, United States, 34655
      • Research Facility
    • Winter Park, Florida, United States, 32789
      • Research Facility
    • Zephyrhills, Florida, United States, 33542
      • Research Facility
  • Georgia
    • Atlanta, Georgia, United States, 30342-5000
      • Research Facility
    • Columbus, Georgia, United States, 31904
      • Research Facility
    • Decatur, Georgia, United States, 30033
      • Research Facility
    • Marietta, Georgia, United States, 30060
      • Research Facility
    • Marietta, Georgia, United States, 30067
      • Research Facility
    • Newnan, Georgia, United States, 30263
      • Research Facility
    • Savannah, Georgia, United States, 31406
      • Research Facility
  • Idaho
    • Boise, Idaho, United States, 83704
      • Research Facility
    • Idaho Falls, Idaho, United States, 83404
      • Research Facility
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Research Facility
    • Berwyn, Illinois, United States, 60402
      • Research Facility
    • Chicago, Illinois, United States, 60637
      • Research Facility
    • Elgin, Illinois, United States, 60123
      • Research Facility
    • Highland Park, Illinois, United States, 60036
      • Research Facility
    • Hoffman Estates, Illinois, United States, 60169
      • Research Facility
    • Homewood, Illinois, United States, 60430
      • Research Facility
    • Lake Barrington, Illinois, United States, 60010
      • Research Facility
    • Oak Lawn, Illinois, United States, 60453
      • Research Facility
    • Peoria, Illinois, United States, 61602
      • Research Facility
    • Urbana, Illinois, United States, 61801
      • Research Facility
  • Indiana
    • Anderson, Indiana, United States, 46016
      • Research Facility
    • Bloomington, Indiana, United States, 47403
      • Research Facility
    • Indianapolis, Indiana, United States, 46202
      • Research Facility
    • Indianapolis, Indiana, United States, 46260
      • Research Facility
    • South Bend, Indiana, United States, 46601
      • Research Facility
  • Iowa
    • Clive, Iowa, United States, 50325
      • Research Facility
    • Davenport, Iowa, United States, 52807
      • Research Facility
    • Waterloo, Iowa, United States, 50701
      • Research Facility
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Research Facility
    • Topeka, Kansas, United States, 66606
      • Research Facility
    • Whichita, Kansas, United States, 67214
      • Research Site
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Research Facility
    • Louisville, Kentucky, United States, 40202
      • Research Facility
    • Louisville, Kentucky, United States, 40291
      • Research Facility
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Facility
    • Lafayette, Louisiana, United States, 70503
      • Research Facility
    • Metairie, Louisiana, United States, 70006
      • Research Facility
    • Monroe, Louisiana, United States, 71201
      • Research Facility
    • Shreveport, Louisiana, United States, 71103
      • Research Facility
  • Maine
    • Bangor, Maine, United States, 04401
      • Research Facility
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Research Facility
    • College Park, Maryland, United States, 20740
      • Research Facility
    • Greenbelt, Maryland, United States, 20770
      • Research Facility
    • Hagerstown, Maryland, United States, 21740
      • Research Facility
    • Hollywood, Maryland, United States, 20636
      • Research Facility
    • Lutherville, Maryland, United States, 21093
      • Research Facility
    • Reisterstown, Maryland, United States, 21136
      • Research Facility
    • Rockville, Maryland, United States, 20850
      • Research Facility
    • Rockville, Maryland, United States, 20854
      • Research Facility
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Facility
    • Boston, Massachusetts, United States, 02215
      • Research Facility
    • Braintree, Massachusetts, United States, 02184
      • Research Facility
    • Southbridge, Massachusetts, United States, 01550
      • Research Facility
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Research Facility
    • Detroit, Michigan, United States, 48201
      • Research Facility
    • Kalamazoo, Michigan, United States, 49048
      • Research Facility
    • Troy, Michigan, United States, 48098
      • Research Facility
    • West Bloomfied, Michigan, United States, 48322
      • Research Facility
    • Wyoming, Michigan, United States, 49519
      • Research Facility
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Research Facility
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Research Facility
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703-6364
      • Research Facility
    • Columbia, Missouri, United States, 65212
      • Research Facility
    • Jefferson City, Missouri, United States, 65109
      • Research Facility
    • Mexico, Missouri, United States, 65265
      • Research Facility
    • St Louis, Missouri, United States, 63128
      • Research Facility
  • Nevada
    • Las Vegas, Nevada, United States, 89147
      • Research Facility
  • New Hampshire
    • Somersworth, New Hampshire, United States, 03878
      • Research Facility
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Research Facility
    • Cedar Knolls, New Jersey, United States, 07927
      • Research Facility
    • Egg Harbor Township, New Jersey, United States, 08234-5857
      • Research Facility
    • Hackensack, New Jersey, United States, 07601
      • Research Site
    • Ocean, New Jersey, United States, 07712
      • Research Facility
    • South Plainfield, New Jersey, United States, 07080
      • Research Facility
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Research Facility
  • New York
    • Babylon, New York, United States, 11702
      • Research Facility
    • Binghamton, New York, United States, 13903
      • Research Facility
    • Brooklyn, New York, United States, 11215
      • Research Facility
    • Brooklyn, New York, United States, 11234
      • Research Facility
    • Cheektowaga, New York, United States, 14225
      • Research Facility
    • Cortland, New York, United States, 13045
      • Research Facility
    • Forest Hills, New York, United States, 10128
      • Research Facility
    • Garden City, New York, United States, 11530
      • Research Facility
    • Great Neck, New York, United States, 11021
      • Research Facility
    • Great Neck, New York, United States, 11023
      • Research Facility
    • Lake Success, New York, United States, 11042
      • Research Facility
    • New York, New York, United States, 10016
      • Research Facility
    • New York, New York, United States, 10028
      • Research Facility
    • Pittsford, New York, United States, 14534
      • Research Facility
    • Port Jefferson Station, New York, United States, 11776
      • Research Facility
    • Rochester, New York, United States, 14621
      • Research Facility
    • Rochester, New York, United States, 14625
      • Research Facility
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Research Facility
    • Charlotte, North Carolina, United States, 28204
      • Research Facility
    • Greensboro, North Carolina, United States, 27403
      • Research Facility
    • Greenville, North Carolina, United States, 27834
      • Research Facility
    • Jacksonville, North Carolina, United States, 28546
      • Research Facility
    • Kinston, North Carolina, United States, 28501
      • Research Facility
    • Morganton, North Carolina, United States, 28655
      • Research Facility
    • Mt Airy, North Carolina, United States, 27030
      • Research Facility
    • Newbern, North Carolina, United States, 28562
      • Research Facility
    • Pinehurst, North Carolina, United States, 28374
      • Research Facility
    • Raleigh, North Carolina, United States, 27607
      • Research Facility
    • Wilmington, North Carolina, United States, 28401
      • Research Facility
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Research Facility
  • Ohio
    • Akron, Ohio, United States, 44302
      • Research Facility
    • Canton, Ohio, United States, 44718
      • Research Facility
    • Cincinnati, Ohio, United States, 45242
      • Research Facility
    • Cincinnati, Ohio, United States, 45219
      • Research Facility
    • Cleveland, Ohio, United States, 44195
      • Research Facility
    • Dayton, Ohio, United States, 45440
      • Research Facility
    • Dayton, Ohio, United States, 45415
      • Research Facility
    • Mentor, Ohio, United States, 44060
      • Research Facility
    • Toledo, Ohio, United States, 43617
      • Research Facility
    • Westlake, Ohio, United States, 44145
      • Research Facility
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Research Facility
  • Oregon
    • Portland, Oregon, United States, 97225
      • Research Facility
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Research Facility
    • Beaver Falls, Pennsylvania, United States, 15010
      • Research Facility
    • Clairton, Pennsylvania, United States, 15025
      • Research Facility
    • Indiana, Pennsylvania, United States, 15701
      • Research Facility
    • Lancaster, Pennsylvania, United States, 17604
      • Research Facility
    • Philadelphia, Pennsylvania, United States, 19106
      • Research Facility
    • Phoenixville, Pennsylvania, United States, 19460
      • Research Facility
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Facility
    • Pittsburgh, Pennsylvania, United States, 15243
      • Research Facility
    • Sewickley, Pennsylvania, United States, 15143
      • Research Facility
    • Souderton, Pennsylvania, United States, 18964
      • Research Facility
    • Uniontown, Pennsylvania, United States, 15401
      • Research Facility
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
      • Research Facility
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Research Facility
    • Columbia, South Carolina, United States, 29204
      • Research Facility
    • Greer, South Carolina, United States, 29651
      • Research Facility
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Research Facility
    • Jackson, Tennessee, United States, 38305
      • Research Facility
    • Memphis, Tennessee, United States, 38104
      • Research Facility
    • Morristown, Tennessee, United States, 37814
      • Research Facility
  • Texas
    • Amarillo, Texas, United States, 79119
      • Research Facility
    • Fort Worth, Texas, United States, 76104
      • Research Facility
    • Greenville, Texas, United States, 75401
      • Research Facility
    • Houston, Texas, United States, 77054
      • Research Facility
    • Houston, Texas, United States, 77004
      • Research Facility
    • Houston, Texas, United States, 77090
      • Research Facility
    • Lewisville, Texas, United States, 75057
      • Research Facility
    • Longview, Texas, United States, 75605
      • Research Facility
    • Odessa, Texas, United States, 79761
      • Research Facility
    • Pasadena, Texas, United States, 77504
      • Research Facility
    • Plano, Texas, United States, 75075
      • Research Facility
    • San Antonio, Texas, United States, 78229
      • Research Facility
  • Utah
    • Ogden, Utah, United States, 84405
      • Research Facility
    • Salt Lake City, Utah, United States, 84107
      • Research Facility
    • West Valley City, Utah, United States, 84120
      • Research Facility
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Research Facility
    • Chesapeake, Virginia, United States, 23320
      • Research Facility
    • Fairfax, Virginia, United States, 22031
      • Research Facility
    • Norfolk, Virginia, United States, 23502
      • Research Facility
    • Virginia Beach, Virginia, United States, 23454
      • Research Facility
    • Winchester, Virginia, United States, 22601
      • Research Facility
  • Washington
    • Seattle, Washington, United States, 98133
      • Research Facility
    • Spokane, Washington, United States, 99204
      • Research Facility
    • Tacoma, Washington, United States, 98405
      • Research Facility
    • Wenatchee, Washington, United States, 98801
      • Research Facility
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Research Facility
    • Monroe, Wisconsin, United States, 53566
      • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry
• At least one flare in the past 18 months
• Utilizing a stable maintenance dose of oral Asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months)
• Females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception

Exclusion Criteria:

• History of or current renal disease
• History of hepatic disease
• History of allergy or hypersensitivity to salicylates, aminosalicylates
• Treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening
• Received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mesalamine (Asacol) Once-Daily; an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Drug: Mesalamine Once-Daily; Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks; Other Names: Asacol QD
Active Comparator: Mesalamine (Asacol) Twice-Daily; an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)	Drug: Mesalamine Twice-Daily; Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks; Other Names: Asacol BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)	Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients Remaining in Remission at Month 3, ITT Population	Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	3 months
Percentage of Patients Remaining in Remission at Month 12, ITT Population	Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	12 months
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population	Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	6 months
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6	MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.	6 months
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6	Is your ulcerative colitis in remission (not active)? Y/N	6 months

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Tom G Todaro, MD, Procter and Gamble

Publications and helpful links

General Publications

• Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 20, 2007
• First Submitted That Met QC Criteria: July 20, 2007
• First Posted (Estimate): July 23, 2007

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: 2007021