A Comparison of Once a Day Dose Compared to 2 Doses/Day - Full Text View

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Mesalamine Once-Daily Drug: Mesalamine Twice-Daily	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: ulcerative colitis

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Mesalamine Mesalamine hydrochloride

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: 6 months ]
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).

Secondary Outcome Measures:

Percentage of Patients Remaining in Remission at Month 3, ITT Population [ Time Frame: 3 months ]
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).
Percentage of Patients Remaining in Remission at Month 12, ITT Population [ Time Frame: 12 months ]
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).
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population [ Time Frame: 6 months ]
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).
Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 [ Time Frame: 6 months ]
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.
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6 [ Time Frame: 6 months ]
Is your ulcerative colitis in remission (not active)? Y/N


Enrollment:	1027
Study Start Date:	July 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Asacol BID

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505778

Show 245 Study Locations

Sponsors and Collaborators

Warner Chilcott

Investigators


Study Director:	Tom G Todaro, MD	Procter and Gamble

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00505778 History of Changes
Other Study ID Numbers:	2007021
Study First Received:	July 20, 2007
Results First Received:	April 18, 2011
Last Updated:	April 15, 2013

Additional relevant MeSH terms:


Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases	Mesalamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on July 18, 2017