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

July 20, 2007
April 15, 2013
July 2007
July 2009   (final data collection date for primary outcome measure)
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).
The primary outcome will be the proportion of patients remaining in remission for each treatment group as determined by the Simple Clinical Colitis Activity Index (SCCAI) at Month 6 [ Time Frame: At 6 months ]
Complete list of historical versions of study NCT00505778 on ClinicalTrials.gov Archive Site
  • 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
Time to relapse/flare measured from baseline to diagnosis of relapse/flare; percentage of patients who remain in remission at Months 3 and 12; adherence to dosing regimen; patient satisfaction with treatment and dosing regimen [ Time Frame: At 3 and 12 months ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: Mesalamine Once-Daily
    Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
    Other Name: Asacol QD
  • Drug: Mesalamine Twice-Daily
    Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks
    Other Name: Asacol BID
  • Active Comparator: Mesalamine (Asacol) Once-Daily
    an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
    Intervention: Drug: Mesalamine Once-Daily
  • Active Comparator: Mesalamine (Asacol) Twice-Daily
    an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
    Intervention: Drug: Mesalamine Twice-Daily
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1027
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00505778
2007021
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Tom G Todaro, MD Procter and Gamble
Warner Chilcott
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP