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
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: 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 August 28, 2014