An increased dose of delayed-release oral mesalamine 4.8 g/day (800 mg Tablet) was found effective for patients with moderately active ulcerative colitis, according to a study published in the December 2009 issue of Gastroenterology.
A six week study (ASCEND III) was conducted to determine the efficiency and safety of mesalamine 4.8 g/day compared to 2.4 g/day for the treatment of moderately active ulcerative colitis (UC). The trial was conducted at 113 sites in 14 countries between July 2006 and June 2007. The patients were males and females between 18 and 75 years of age with a diagnosis of moderately active UC. Moderately active UC was defined as a Physician's Global Assessment (PGA) equal to 2 points, with a score of less than or equal to one point in both stool frequency and rectal bleeding clinical assessment and a score of less than or equal to two points in the sigmoidoscopy assessment with a positive friability (degree of fragility) assessment. Patients were excluded from participation if they had UC confined to the rectum, short bowel syndrome, renal or hepatic disease, or a stool examination positive for Clostridium difficile, bacterial pathogens, or ova and parasites. Other exclusion criteria were an allergy to salicylates,aminosalicylates, or any component of the delayed-release mesalamine tablets, a history of HIV infection or AIDS, a history of alcohol or drug abuse, and women who were pregnant or breastfeeding. The study participants were prohibited from taking certain medications that might interfere with the evaluation of the study medication.
Eligible patients were randomized to receive either oral delayed-release mesalamine 2.4 g/day (Asacol 400 mg tablet) or delayed-release mesalamine 4.8 g/day (Asacol HD 800 mg tablet). Patients were assessed at screening and weeks 0 (baseline), 3 and 6. Treatment success was defined as either a complete response (remission) or a partial response (improvement) to treatment from baseline to week 6.
The ASCEND III study design was amended with the sample size increased from 470 to 770 patients.