← Back to Search

Aminosalicylate

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

Phase 3
Waitlist Available
Research Sponsored by Warner Chilcott
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions

Summary

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.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)
Secondary study objectives
Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population
Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6
Percentage of Patients Remaining in Remission at Month 12, ITT Population
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Active Control
Group I: Mesalamine (Asacol) Twice-DailyActive Control1 Intervention
an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
Group II: Mesalamine (Asacol) Once-DailyActive Control1 Intervention
an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)

Find a Location

Who is running the clinical trial?

Warner ChilcottLead Sponsor
60 Previous Clinical Trials
24,200 Total Patients Enrolled
7 Trials studying Colitis
1,704 Patients Enrolled for Colitis
Tom G Todaro, MDStudy DirectorProcter and Gamble
1 Previous Clinical Trials
214 Total Patients Enrolled
~56 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top