Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

February 11, 2008

Start Date ^ICMJE

February 2001

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the proportion of patients in each treatment group who improved from baseline at Week 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00577473 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

patient improvement at Week 3, sigmoidoscopic and clinical improvement (stool frequency, rectal bleeding, PGA, and PFA), and quality of life (Inflammatory Bowel Disease Questionnaire) at Weeks 3 and 6. [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

Drug: mesalamine

Study Arms / Comparison Groups

Active Comparator: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
Experimental: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

308

Completion Date

February 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 resectio

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00577473

Responsible Party

Piotr Krzeski, MD, Procter and Gamble

Study ID Numbers ^ICMJE

2000083

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jeffery Kralstein, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP