A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350415
• Other study ID #: 2006444
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2006
• Last updated: April 15, 2013
• Start date: June 2006
• Est. completion date: May 2007

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

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.

Other known NCT identifiers

• NCT00336440

Recruitment information / eligibility

• Status: Completed
• Enrollment: 772
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Belarus	Research Facility	Gornel	Gormel
Belarus	Research Facility	Grodno
Belarus	Research Facility	Minsk
Belarus	Research Facility	Vitebsk
Canada	Research Facility	Abbotsford	British Columbia
Canada	Research Facility	Edmonton	Alberta
Canada	Research Facility	Guelph	Ontario
Canada	Research Facility	Hamilton	Ontario
Canada	Research Facility	Levis	Quebec
Canada	Research Facility	London	Ontario
Canada	Research Facility	Longheuil	Quebec
Canada	Research Facility	Montreal	Quebec
Canada	Research Facility	Ottawa	Ontario
Canada	Research Facility	Quebec
Canada	Research Facility	Quebec City	Quebec
Canada	Research Facility	Rimouski	Quebec
Canada	Research Facility	Saskatoon	Saskatchewan
Canada	Research Facility	Toronto	Ontario
Canada	Research Facility	Vancouver	British Columbia
Croatia	Research Facility	Rijeka
Croatia	Research Facility	Zagreb
Czech Republic	Research Facility	Kralove
Czech Republic	Research Facility	Pavlov
Czech Republic	Research Facility	Praha 2
Czech Republic	Research Facility	Strakonice
Czech Republic	Research Facility	Usti nad Labem
Estonia	Research Facility	Tallinn
Estonia	Research Facility	Tartu
Hungary	Research Facility	Argenti Dome ter
Hungary	Research Facility	Budapest
Hungary	Research Facility	Nagyerdei krt
Latvia	Research Facility	Riga
Lithuania	Research Facility	Kaunas
Lithuania	Research FacilityPanevezys	Panevezys
Lithuania	Research Facility	Santariskiu	Vilnius
Poland	Research Facility	Bydgoszcz
Poland	Research Facility	Czestochowa
Poland	Research Facility	Krakow
Poland	Research Facility	Lodz
Poland	Research Facility	Pruszkow
Poland	Research Facility	Sopot
Poland	Research Facility	Warszawa
Poland	Research Facility	Wtoctawek
Puerto Rico	Research Facility	San Juan
Romania	Research Facility	Bucuresti 1	Bucuresti
Romania	Research Facility	Cluj-napoca
Romania	Research Facility	Iasi
Russian Federation	Research Facility	Moscow	Mowcow
Russian Federation	Research Facility	Nizhny Novgorod
Russian Federation	Research Facility	St. Petersburg
Serbia	Research Facility	Beograd
Serbia	Research Facility	Novi Sad
Ukraine	Research Facility	Kharkiv
Ukraine	Research Facility	Kyiv
Ukraine	Research Facility	Simpheropol
Ukraine	Research Facility	Zabolotnogo	Odesa
Ukraine	Research Facility	Zaporizhzhya
United States	Research Facility	Akron	Ohio
United States	Research Facility	Alabaster	Alabama
United States	Research Facility	Anaheim	California
United States	Research Facility	Arlington Heights	Illinois
United States	Research Facility	Atlanta	Georgia
United States	Research Facility	Austin	Texas
United States	Research Facility	Baltimore	Maryland
United States	Research Facility	Baton Rouge	Louisiana
United States	Research Facility	Beaver Falls	Pennsylvania
United States	Research Facility	Binghamton	New York
United States	Research Facility	Birmingham	Alabama
United States	Research Facility	Bismarck	North Dakota
United States	Research Facility	Boston	Massachusetts
United States	Research Facility	Burbank	California
United States	Research Facility	Burlington	Vermont
United States	Research Facility	Charlotte	North Carolina
United States	Research Facility	Chesapeake	Virginia
United States	Research Facility	Chevy Chase	Maryland
United States	Research Facility	Chicago	Illinois
United States	Research Facility	Cincinnati	Ohio
United States	Research Facility	Columbia	South Carolina
United States	Research Facility	Columbia	Michigan
United States	Research Facility	Dayton	Ohio
United States	Research Facility	Deland	Florida
United States	Research Facility	Egg Harbor Township	New Jersey
United States	Research Facility	Encinitas	California
United States	Research Facility	Fargo	North Dakota
United States	Research Facility	Fayetteville	Arkansas
United States	Research Facility	Garden City	New York
United States	Research Facility	Great Neck	New York
United States	Research Facility	Hamden	Connecticut
United States	Research Facility	Harbor	Florida
United States	Research Facility	Hollywood	Florida
United States	Research Facility	Huntington	New York
United States	Research Facility	Jacksonville	Florida
United States	Research Facility	Kansas City	Missouri
United States	Research Facility	Kingsport	Tennessee
United States	Research Facility	Lakewood	Colorado
United States	Research Facility	Little Rock	Arkansas
United States	Research Facility	Littleton	Colorado
United States	Research Facility	Los Angeles	California
United States	Research Facility	Los Angeles	California
United States	Research Facility	Louisville	Kentucky
United States	Research Facility	Memphis	Tennessee
United States	Research Facility	Milwaukee	Wisconsin
United States	Research Facility	Minneapolis	Minnesota
United States	Research Facility	Mission Hills	California
United States	Research Facility	Murray	Utah
United States	Research Facility	Nashville	Tennessee
United States	Research Facility	New York	New York
United States	Research Facility	Ogden	Utah
United States	Research Facility	Omaha	Nebraska
United States	Research Facility	Orange	California
United States	Research Facility	Panama City	Florida
United States	Research Facility	Pasadena	California
United States	Research Facility	Philadelphia	Pennsylvania
United States	Research Facility	Portland	Oregon
United States	Research Facility	Redmond	Washington
United States	Research Facility	Reisterstown	Maryland
United States	Research Facility	Rochester	Minnesota
United States	Research Facility	Rochester	New York
United States	Research Facility	Roseville	California
United States	Research Facility	Sacramento	California
United States	Research Facility	San Antonio	Texas
United States	Research Facility	San Carlos	California
United States	Research Facility	San Francisco	California
United States	Research Facility	Savannah	Georgia
United States	Research Facility	Scottsbluff	Nebraska
United States	Research Facility	Shreveport	Louisiana
United States	Research Facility	St. Louis	Missouri
United States	Research Facility	Topeka	Kansas
United States	Research Facility	Troy	New York
United States	Research Facility	Tucson	Arizona
United States	Research Facility	Tupelo	Mississippi
United States	Research Facility	Warren	Ohio
United States	Research Facility	Wilmington	North Carolina
United States	Research Facility	York	Pennsylvania
United States	Research Facility	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

United States,  Belarus,  Canada,  Croatia,  Czech Republic,  Estonia,  Hungary,  Latvia,  Lithuania,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients (ITT) in each treatment group who achieve treatment success, defined as symptomatic and endoscopic improvement from baseline at Week 6.		Week 6	No
Secondary	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.		week 3 and 6	No

External Links

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