Official Title: “A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation”

To evaluate the long-term safety and tolerability of mesalamine pellets (MP)in patients with ulcerative colitis currently in remission.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

This is a Phase 3, multicenter, open-label, treatment extension study evaluating the long-term safety and tolerability of encapsulated mesalamine pellets (MP) given QD in subjects who successfully participated in a previous MP study or in subjects who are currently in remission from symptoms of ulcerative colitis.

Intervention(s) in this Clinical Trial

• Drug: Mesalamine pellets

Inclusion Criteria:

• 1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities.
• 2. Subject has successfully participated in a previous MP clinical study per investigator's discretion with successful participation minimally defined as compliant with study-related procedures and study drug dosing schedule in the previous study and did not discontinue from the previous study due to study drug-related AE(s) or if new subjects:
• a. Subject is a male or,

If the subject is female, she is eligible to enter if she is of:

• Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses); OR,
• Childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
• i) Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 6-month
• Treatment Phase, and the 2-week follow-up phase.
• ii) Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
• iii) An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is <1% per year (not all IUDs meet this criterion).
• iv) Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion.
• Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion v) Partner has undergone vasectomy and subject is in a monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
• b. Subject is ≥18 years of age. c. Subject has historically confirmed diagnosis (physician letter for newly/recently diagnosed and by medical records for previously diagnosed subjects) of mild to moderate UC in remission for >1 month and <12 months.
• d. Confirmed current remission defined as both: A screening rectal bleeding score of 0 as described in the Disease Activity Index (DAI) (Sutherland Index) where 0 = None A screening sigmoidoscopy score of 0 to 1 for mucosal appearance as described in the (Sutherland Index where 0 = intact mucosa with preserved or distorted vessels and 1 =
• Erythema, decreased vascular pattern, granularity, no mucosal hemorrhage (see ;
• Appendix 2 for a copy of the entire Index).
• 3. Subject and investigator consider there is the potential for benefit to the subject with MP treatment.
• 4. Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

• 1. Subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.

If a new subject, the following additional exclusion criteria will apply:

• 2. Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
• 3. Subject has an abnormal clinical lab result which in the opinion of the investigator is significant enough to prevent subject's enrollment in the study.
• 4. Subject or subject's parents are known to have phenylketonuria.
• 5. Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
• 6. Subject shows evidence of current excessive alcohol consumption or drug dependence.
• 7. Subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine or blood urea nitrogen (BUN) levels.
• 8. Subject has calculated creatinine clearance level of < 60 mL/min

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Salix Pharmaceuticals

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00326209

Study ID Number: MPUC3005

ClinicalTrials.gov Identifier: NCT00326209

Health Authority: United States: Food and Drug Administration