A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Official Title: “A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.”

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Intervention(s) in this Clinical Trial

• Drug: Mesalamine
  • Asacol 400g/day (400 mg tablet), oral, for 6 weeks OR Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Asacol 2.4 g/day (400 mg tablet)
• Active Comparator: 2
  • Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks

Primary Measures

• Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
  • Time Frame: Week 6
    Safety Issue?: No

Secondary Measures

• Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
  • Time Frame: week 3 and 6
    Safety Issue?: No

Inclusion Criteria:

• Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
• Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

• Patients with isolated proctitis
• Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Piotr Krzeski, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350415

Study ID Number: 2006444

ClinicalTrials.gov Identifier: NCT00350415

Health Authority: United States: Food and Drug Administration