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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505778
First Posted: July 23, 2007
Last Update Posted: April 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Warner Chilcott
  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 (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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00505778     History of Changes
Other Study ID Numbers: 2007021
First Submitted: July 20, 2007
First Posted: July 23, 2007
Results First Submitted: April 18, 2011
Results First Posted: May 12, 2011
Last Update Posted: April 22, 2013
Last Verified: April 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


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