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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577473
First received: December 19, 2007
Last updated: September 14, 2011
Last verified: September 2011

December 19, 2007
September 14, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577473
2000083
No
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