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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00505778
First received: July 20, 2007
Last updated: April 15, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety/Efficacy Study
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:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00505778

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Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Tom G Todaro, MD Procter and Gamble
  More Information

No publications provided by Warner Chilcott

Additional 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
Study First Received: July 20, 2007
Results First Received: April 18, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014