A Double Blind Study for the Treatment of Acute Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00350415
First received: July 6, 2006
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention Phase
Ulcerative Colitis
Drug: Mesalamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 772
Study Start Date: June 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Asacol 2.4 g/day (400 mg tablet)
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

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


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350415

  Show 135 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Piotr Krzeski, MD Procter and Gamble
  More Information

Additional Information:
No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00350415     History of Changes
Obsolete Identifiers: NCT00336440
Other Study ID Numbers: 2006444
Study First Received: July 6, 2006
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
ulcerative colitis, inflammatory bowel disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on October 16, 2014