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Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) (ASCEND I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577473
First Posted: December 20, 2007
Last Update Posted: September 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Warner Chilcott
December 19, 2007
December 20, 2007
May 24, 2011
June 22, 2011
September 16, 2011
February 2001
February 2003   (Final data collection date for primary outcome measure)
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population [ Time Frame: 6 weeks ]
Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
the proportion of patients in each treatment group who improved from baseline at Week 6 [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00577473 on ClinicalTrials.gov Archive Site
  • Percentage of Patients Classified as Treatment Success at Week 3, ITT Population [ Time Frame: 3 weeks ]
    Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
  • Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients [ Time Frame: Week 3 ]
    PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
  • Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients [ Time Frame: Week 6 ]
    PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
  • Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ]
    0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.
  • Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ]
    0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse.
  • Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ]
    0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse.
  • Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ]
    0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse.
  • Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ]
    0-generally well, 1-fair, 2-poor, 3-terrible
  • Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ]
    0-generally well, 1-fair, 2-poor, 3-terrible
  • Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ]
    0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.
  • Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ]
    0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse.
patient improvement at Week 3, sigmoidoscopic and clinical improvement (stool frequency, rectal bleeding, PGA, and PFA), and quality of life (Inflammatory Bowel Disease Questionnaire) at Weeks 3 and 6. [ Time Frame: 3 and 6 weeks ]
Not Provided
Not Provided
 
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: mesalamine
    mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
  • Drug: mesalamine
    mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
  • Active Comparator: 1
    mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
    Intervention: Drug: mesalamine
  • Experimental: 2
    mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
    Intervention: Drug: mesalamine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
301
February 2003
February 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • confirmed diagnosis of ulcerative colitis

Exclusion Criteria:

  • a history of allergy or hypersensitivity to salicylates or aminosalicylates;
  • a history of extensive small bowel resection
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00577473
2000083
No
Not Provided
Not Provided
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Jeffery Kralstein, MD Procter and Gamble
Warner Chilcott
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP