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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.
Study NCT00073021   Information provided by Procter and Gamble
First Received: November 13, 2003   Last Updated: July 17, 2009   History of Changes

November 13, 2003
July 17, 2009
September 2000
September 2003   (final data collection date for primary outcome measure)
patients who at the end of 6 weeks were classified as a success [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00073021 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Ulcerative Colitis
  • Drug: Asacol (mesalamine)
  • Drug: asacol 400 mg (mesalamine)
  • Active Comparator: Asacol (2.4 g/day)
  • Experimental: Asacol (800 mg/day)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
301
September 2003
September 2003   (final data collection date for primary outcome measure)

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 pregancy test, or lactating.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00073021
Piotr Krzeski, MD, Procter and Gamble Pharmaceuticals
200082
Procter and Gamble
 
Study Director: Piotr Krzeski, MD Procter and Gamble
Procter and Gamble
July 2009

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