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”

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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Asacol
  • an oral, once daily (QD) Asacol regimen (1.6g/day to 2.4g/day
• Drug: Asacol
  • an oral, twice daily Asacol regimen (1.6g/day to 2.4g/day)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • an oral, once daily (QD) Asacol regimen (1.6g/day to 2.4g/day)
• Active Comparator: 1
  • an oral, twice daily Asacol regimen (1.6g/day to 2.4g/day)

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Tom G Todaro, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00505778

Study ID Number: 2007021

ClinicalTrials.gov Identifier: NCT00505778

Health Authority: United States: Food and Drug Administration