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
  Purpose

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


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 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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 301
Study Start Date: February 2001
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Experimental: 2
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Drug: mesalamine
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577473

  Show 44 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Jeffery Kralstein, MD Procter and Gamble
  More Information

No publications provided by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577473     History of Changes
Other Study ID Numbers: 2000083
Study First Received: December 19, 2007
Results First Received: May 24, 2011
Last Updated: September 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014