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Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00073021
First received: November 13, 2003
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.


Condition Intervention Phase
Ulcerative Colitis
 Drug: Asacol 800 mg (mesalamine)
Drug: Asacol 400 mg (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 to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)


Secondary Outcome Measures:
  • Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [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 and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]

  • Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 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)

  • Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Sigmoidoscopy Assessment Score (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)

  • Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 [ Time Frame: 6 Weeks ] [ 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

  • Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Rectal Bleeding (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)

  • Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    PFA - 0=generally well, 1=fair, 2=poor, 3=terrible

  • Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.

  • Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.

  • Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.

  • Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)

  • Percentage of Treatment Success Patients at Week 3, ITT Population [ Time Frame: 3 Weeks ] [ Designated as safety issue: No ]
    Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)


Enrollment: 386
Study Start Date: September 2000
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Asacol 2.4 g/day
Asacol (2.4 g/day)
 Drug: Asacol 400 mg (mesalamine)
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Experimental: Asacol 4.8 g/day
Asacol (4.8 g/day)
 Drug: Asacol 800 mg (mesalamine)
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female between 18 and 75 years of age;
  • have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
  • currently demonstrating moderately active disease

Exclusion Criteria:

Patients will be excluded from admission to the study if they have/are:

  • a history of allergy or hypersensitivity to salicylates or aminosalicylates;
  • a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
  • current renal or hepatic disease;
  • participated in any drug or device clinical study within 30 days of entry;
  • currently enrolled in any other clinical study;
  • received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
  • received any other topical rectal therapy during the week prior to the Screening Visit;
  • received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
  • received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
  • received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
  • received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
  • if female, positive pregnancy test, or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073021

  Show 57 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Piotr Krzeski, 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: NCT00073021     History of Changes
Other Study ID Numbers: 2000082
Study First Received: November 13, 2003
Results First Received: March 25, 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 May 23, 2013