A Double Blind Study for the Treatment of Acute Ulcerative Colitis

April 15, 2013 updated by: Warner Chilcott

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, multi-center, multi-national, active-control study in patients who are experiencing a moderately active flare of UC. Patients will be randomly assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1 ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient population. Following successful screening, patients will be randomized to one of the two treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit after 3 weeks.

Study Type

Interventional

Enrollment (Actual)

772

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Grodno, Belarus, 230017
        • Research Facility
      • Minsk, Belarus, 220013
        • Research Facility
      • Vitebsk, Belarus, 210037
        • Research Facility
    • Gormel
      • Gornel, Gormel, Belarus
        • Research Facility
  • Canada
      • Quebec, Canada, G1L 3L5
        • Research Facility
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • Research Facility
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3N5
        • Research Facility
      • Vancouver, British Columbia, Canada, V5Z 112
        • Research Facility
    • Ontario
      • Guelph, Ontario, Canada, N1H 3R3
        • Research Facility
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Research Facility
      • London, Ontario, Canada, N6A 5K8
        • Research Facility
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Facility
      • Toronto, Ontario, Canada, M3N 2V7
        • Research Facility
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Research Facility
      • Longheuil, Quebec, Canada, J4N 1E1
        • Research Facility
      • Montreal, Quebec, Canada, H31 1E2
        • Research Facility
      • Quebec City, Quebec, Canada, G1R 2J6
        • Research Facility
      • Rimouski, Quebec, Canada, G5L 5T1
        • Research Facility
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
        • Research Facility
  • Croatia
      • Rijeka, Croatia, 51000
        • Research Facility
      • Zagreb, Croatia, 10000
        • Research Facility
  • Czech Republic
      • Kralove, Czech Republic, 500 12
        • Research Facility
      • Pavlov, Czech Republic
        • Research Facility
      • Praha 2, Czech Republic, 120 00
        • Research Facility
      • Strakonice, Czech Republic, 3886 29
        • Research Facility
      • Usti nad Labem, Czech Republic, 401 13
        • Research Facility
  • Estonia
      • Tallinn, Estonia, 10138
        • Research Facility
      • Tartu, Estonia, 51014
        • Research Facility
  • Hungary
      • Argenti Dome ter, Hungary, 1-3
        • Research Facility
      • Budapest, Hungary
        • Research Facility
      • Nagyerdei krt, Hungary, 98
        • Research Facility
  • Latvia
      • Riga, Latvia, LV-1002
        • Research Facility
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Research Facility
      • Panevezys, Lithuania, LT-35144
        • Research FacilityPanevezys
    • Vilnius
      • Santariskiu, Vilnius, Lithuania, LT-08661
        • Research Facility
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Research Facility
      • Czestochowa, Poland, 42-200
        • Research Facility
      • Krakow, Poland, 31-501
        • Research Facility
      • Lodz, Poland, 90-153
        • Research Facility
      • Pruszkow, Poland, 05-800
        • Research Facility
      • Sopot, Poland, 81-756
        • Research Facility
      • Warszawa, Poland, 02-57
        • Research Facility
      • Wtoctawek, Poland, 87-800
        • Research Facility
  • Puerto Rico
      • San Juan, Puerto Rico, 5067
        • Research Facility
  • Romania
      • Cluj-napoca, Romania, 400162
        • Research Facility
      • Iasi, Romania, 700111
        • Research Facility
    • Bucuresti
      • Bucuresti 1, Bucuresti, Romania, 010825
        • Research Facility
  • Russian Federation
      • Nizhny Novgorod, Russian Federation, 603126
        • Research Facility
      • St. Petersburg, Russian Federation, 196247
        • Research Facility
    • Mowcow
      • Moscow, Mowcow, Russian Federation, 129110
        • Research Facility
  • Serbia
      • Beograd, Serbia, 11080
        • Research Facility
      • Novi Sad, Serbia, 21000
        • Research Facility
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Research Facility
      • Kyiv, Ukraine, 04053
        • Research Facility
      • Simpheropol, Ukraine, 95000
        • Research Facility
      • Zaporizhzhya, Ukraine, 69050
        • Research Facility
    • Odesa
      • Zabolotnogo, Odesa, Ukraine, 65025
        • Research Facility
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • Research Facility
      • Birmingham, Alabama, United States, 35209
        • Research Facility
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Research Facility
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Research Facility
      • Little Rock, Arkansas, United States, 72205
        • Research Facility
    • California
      • Anaheim, California, United States, 92801
        • Research Facility
      • Burbank, California, United States, 91505
        • Research Facility
      • Encinitas, California, United States, 93024
        • Research Facility
      • Los Angeles, California, United States, 90067
        • Research Facility
      • Los Angeles, California, United States, 90274
        • Research Facility
      • Mission Hills, California, United States, 91345
        • Research Facility
      • Orange, California, United States, 92868
        • Research Facility
      • Pasadena, California, United States, 91105
        • Research Facility
      • Roseville, California, United States, 95661
        • Research Facility
      • Sacramento, California, United States, 95825
        • Research Facility
      • San Carlos, California, United States, 94070
        • Research Facility
      • San Francisco, California, United States, 94115
        • Research Facility
    • Colorado
      • Lakewood, Colorado, United States, 80215
        • Research Facility
      • Littleton, Colorado, United States, 80120
        • Research Facility
    • Connecticut
      • Hamden, Connecticut, United States, 06518-3691
        • Research Facility
    • Florida
      • Deland, Florida, United States, 32720
        • Research Facility
      • Harbor, Florida, United States, 34684
        • Research Facility
      • Hollywood, Florida, United States, 33021
        • Research Facility
      • Jacksonville, Florida, United States, 32256
        • Research Facility
      • Panama City, Florida, United States, 33405
        • Research Facility
      • Zephyrhills, Florida, United States, 33542
        • Research Facility
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Research Facility
      • Savannah, Georgia, United States, 31405
        • Research Facility
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Research Facility
      • Chicago, Illinois, United States, 60637
        • Research Facility
    • Kansas
      • Topeka, Kansas, United States, 60606
        • Research Facility
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • Research Facility
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Research Facility
      • Shreveport, Louisiana, United States, 71103
        • Research Facility
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Research Facility
      • Chevy Chase, Maryland, United States, 20815
        • Research Facility
      • Reisterstown, Maryland, United States, 21136
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Facility
    • Michigan
      • Columbia, Michigan, United States, 65212
        • Research Facility
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Research Facility
      • Rochester, Minnesota, United States, 55905
        • Research Facility
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Facility
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Research Facility
      • St. Louis, Missouri, United States, 63128
        • Research Facility
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Research Facility
      • Scottsbluff, Nebraska, United States, 69361
        • Research Facility
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Research Facility
    • New York
      • Binghamton, New York, United States, 13903
        • Research Facility
      • Garden City, New York, United States, 11530
        • Research Facility
      • Great Neck, New York, United States, 11021
        • Research Facility
      • Huntington, New York, United States, 11743
        • Research Facility
      • New York, New York, United States, 10021
        • Research Facility
      • Rochester, New York, United States, 14642
        • Research Facility
      • Troy, New York, United States, 12180
        • Research Facility
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Research Facility
      • Wilmington, North Carolina, United States, 28401
        • Research Facility
    • North Dakota
      • Bismarck, North Dakota, United States, 58501-1640
        • Research Facility
      • Fargo, North Dakota, United States, 58104
        • Research Facility
    • Ohio
      • Akron, Ohio, United States, 44302
        • Research Facility
      • Cincinnati, Ohio, United States, 45242
        • Research Facility
      • Dayton, Ohio, United States, 45440
        • Research Facility
      • Warren, Ohio, United States, 44484
        • Research Facility
    • Oregon
      • Portland, Oregon, United States, 97220
        • Research Facility
    • Pennsylvania
      • Beaver Falls, Pennsylvania, United States, 15010
        • Research Facility
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Facility
      • York, Pennsylvania, United States, 17403
        • Research Facility
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Research Facility
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Research Facility
      • Memphis, Tennessee, United States, 38120
        • Research Facility
      • Nashville, Tennessee, United States, 37232
        • Research Facility
    • Texas
      • Austin, Texas, United States, 78743
        • Research Facility
      • San Antonio, Texas, United States, 78205
        • Research Facility
    • Utah
      • Murray, Utah, United States, 84107
        • Research Facility
      • Ogden, Utah, United States, 84405
        • Research Facility
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Facility
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Facility
    • Washington
      • Redmond, Washington, United States, 98052
        • Research Facility
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.
  • Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

  • Patients with isolated proctitis
  • Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Asacol 2.4 g/day (400 mg tablet)
Drug: Mesalamine

Asacol 400g/day (400 mg tablet), oral, for 6 weeks

OR

Asacol 4,8 g/day (800 mg table), oral, for 6 weeks
Active Comparator: 2
Asacol 4,8 g/day (800 mg tablet), oral, for 6 weeks
Drug: Mesalamine

Asacol 400g/day (400 mg tablet), oral, for 6 weeks

OR

Asacol 4,8 g/day (800 mg table), oral, for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.
Time Frame: Week 6
Week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients (ITT) in pre-defined subgroups in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6 and Week 3.
Time Frame: week 3 and 6
week 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Piotr Krzeski, MD, Procter and Gamble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006444

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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