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
  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:


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
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: 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 July 31, 2014