Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis
Brief Summary: 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.


Options:
A: 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 pregnancy test, or lactating.
B: Inclusion Criteria:

1. More than 18 years of age
2. Patients suffering from one of the following chronic inflammatory intestinal disease:

   * Steroid-dependent Chron's Disease or Ulcerative Colitis following ECCO definition or mild-moderate active UC ( Powell Tuck between 3 and 14- an index of 14 was allowed; endoscopic Baron score \>1) refractory to mesalazine.
3. Disease extension over the rectum (at least 15 cm) in patients suffering from Ulcerative Colitis
4. Patients willing and be able to give written informed consent.

Exclusion Criteria:

1. Intestinal sub occlusion or a suspected abdomen abscess or a severe degree of the disease (CDAI \> 450) in patient suffering from Chron's Disease
2. Patient affected by a severe Ulcerative Colitis (more than 6 evacuations of liquid, mucous-blooding stools combined at least one systemic sign as body temperature \> 37.8 °C, heart rate \< 90 bpm, ESR \> 30 mm/h or haemoglobin \< 10.5 g/dL)
3. Severe concurrent disease(s) as:

   * Medullar deficit: white blood cells \< 3000/mm3; platelets \< 75000/mm3; haemoglobin \< 10 g/dL;
   * Hepatic diseases presenting total bilirubin ≥ 3 mg/dL; AST (GOT) ≥ 5 UNL; alkaline phosphatase ≥ 5 UNL:
   * Renal failure with serum creatinine ≥ 3 mg/dL;
   * Heart failure
   * Respiratory failure
   * Disabling neurological diseases
   * Neoplasia
   * Patient deemed candidate to surgery due to Chron's Disease or Ulcerative Colitis
   * Chronic alcohol or drug abuse
   * Patient for whom the use of steroids is contraindicated (e.g. systemic infections)
4. Treatment with Infliximab in the previous 4 months
5. Pregnant woman or female for whom the possibility of a pregnancy during the study could not be excluded.
6. Non-collaborating patient or subject unable to regularly undergo the scheduled study procedures.
C: Inclusion Criteria:

* Subjects must have completed all assessments of SPD476-301 or SPD476-302 End of Study/Early Withdrawal Visit
* Subjects who did not achieve remission at the End of Study/Early Withdrawal Visits in Study 301 or 302 will be eligible to enter the Acute Phase; subjects who did achieve remission at the End of Study Visits in Study 301 or 302 will be eligible to enter directly into the Maintenance Phase
* Women of childbearing potential must use an acceptable contraceptive method while on study treatment

Exclusion Criteria:

* Subjects who withdrew from Study 301 or 302 before Study Visit 3, or who withdrew due to a possible or probably related severe adverse event or serious adverse event are not eligible to enter this study
D: Inclusion Criteria:

* Men and women 18 years or older who have given written Informed Consent
* Patients with proven ulcerative colitis
* Active disease course for the last 6 weeks or longer with bloody diarrhea
* Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.

Exclusion Criteria:

* Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
* Crohn's disease,
* Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,
* Treatment with other investigational medicinal product within 3 months prior to study entry

Answer: A