A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

Inclusion Criteria: Adults with newly diagnosed ulcerative colitis or with relapse following prior treatmentand who met all the following criteria were eligible for participation in the study:

1. IRB approved consent form signed and dated prior to any study-related activities

2. Male or, if female, had undergone sterilization (hysterectomy or bilateral tuballigation), was post-menopausal (defined as 1 year without menses) or has a negativepregnancy test at screening and, if heterosexually active, had used and agreed tocontinue to use: double-barrier method of contraception (condom and spermicide), oralor patch contraceptives, intrauterine device, or was in a monogamous relationship witha partner who had undergone a vasectomy.

3. 18 years of age or older

4. Newly diagnosed with ulcerative colitis or relapsed following prior treatment

5. Patient had not taken > 1.6 g/day of mesalamine or equivalent for 14 days prior torandomization

6. Disease extending ≥ 15 cm above the anal verge on screening sigmoidoscopy orcolonoscopy with confirming biopsy

7. Mild to moderate ulcerative colitis, defined as a Disease Activity Index (DAI) scorebetween 4 and 9, inclusive, at study entry, and with a PGA of 1 or 2 and mucosalappearance (determined by endoscopy exam) score of 1 or 2 (mild/moderate)

8. Able and willing to have kept a daily diary during the study

Exclusion Criteria:

1. Treatment with topical rectal, oral, or intravenous (IV) corticosteroids within 30days of screening or immunosuppressives (e.g. azathioprine, 6-mercaptopurine) withinthe 90 days immediately preceding Screening

2. Use of rectal - administered aminosalicylates within 7 days of randomization

3. Patient had taken greater than 1.6 g/day of mesalamine or equivalent within 14 days ofrandomization

4. Crohn's disease, ischemic colitis, or disease of bacterial origin

5. Known allergy or hypersensitivity to aspirin or salicylate compounds

6. History of or laboratory results showing significant hepatic or renal disease or othersignificant medical condition which in the opinion of the investigator precludedparticipation in the study based on efficacy/safety assessments

7. History of cancer other than basal cell carcinoma within the five years immediatelypreceding study entry

8. In relapse for > 3 weeks prior to the screening visit

9. Proctitis below 15 cm from the anal verge

10. History of or current gastrointestinal bleeding other than bloody stools associatedwith ulcerative colitis

11. History of bleeding disorder

12. Active peptic ulcer disease, history of gastrointestinal obstruction including severeconstipation, or anatomic abnormality of the GI tract

13. Previous colonic surgery

14. History of alcohol or other substance abuse within the year immediately precedinganticipated study entry

15. HIV positive

16. > 6 bloody stools per day

17. Positive stool culture for ova and/or parasites, enteric pathogens includingSalmonella, Shigella, Yersinia, and Campylobacter, or positive stool assay for C.difficile toxin

18. Pregnant or breast feeding

19. Used an investigational drug in the 30 days prior to randomization

20. BUN or serum creatinine levels of 1.5 times the upper limit of normal (ULN) or liverenzyme levels > 2 times the ULN