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

July 6, 2006
April 15, 2013
June 2006
May 2007   (final data collection date for primary outcome measure)
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 ]
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Complete list of historical versions of study NCT00350415 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
A Double Blind Study for the Treatment of Acute 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 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
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

  • Experimental: 1
    Asacol 2.4 g/day (400 mg tablet)
    Intervention: Drug: Mesalamine
  • Active Comparator: 2
    Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
    Intervention: Drug: Mesalamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
772
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States,   Belarus,   Ukraine,   Croatia,   Czech Republic,   Estonia,   Hungary,   Latvia,   Lithuania,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia
 
NCT00350415
2006444
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Piotr Krzeski, 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