Asacol Acute Diverticulitis(DIVA)Study

• Percentage of Responders at Week 12 - ITT Population [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
• Percentage of Responders at Week 52 - ITT Population [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
• Change in GSS From Baseline to Week 12 - ITT Population [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
• Change in GSS From Baseline to Week 52 - ITT Population [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).
• Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Recurrent Diverticulitis, Percentage, ITT Population, Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).
• Recurrent Diverticulitis, Percentage, ITT Population, Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is safe and effective in the treatment of diverticulitis.

This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally healthy, adult patients who have had an attack of acute diverticulitis. The study will evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month non-treatment observation period in approximately 180 patients with acute diverticulitis.

• Drug: Mesalamine
  6 - 400 mg tablets once daily
• Drug: Probiotic
  Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
  Other Name: Align
• Drug: Placebo
  6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
• Other: Dietary Advice
  Dietary advice
• Drug: Antibiotic for Diverticulitis
  Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

• Placebo Comparator: Placebo
  Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.
  Interventions:

  • Drug: Placebo
  • Other: Dietary Advice
  • Drug: Antibiotic for Diverticulitis
• Active Comparator: Mesalamine
  Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.
  Interventions:

  • Drug: Mesalamine
  • Other: Dietary Advice
  • Drug: Antibiotic for Diverticulitis
• Active Comparator: Mesalamine & Probiotic
  Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily
  Interventions:

  • Drug: Probiotic
  • Other: Dietary Advice
  • Drug: Antibiotic for Diverticulitis

Inclusion Criteria:

• A clinical diagnosis of acute diverticulitis
• Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
• Willing and able to participate in the study and provide a signed informed consent

Exclusion Criteria:

• Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
• Active or recent history (within 6 months) of a peptic ulcer;
• Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
• History of major abdominal surgery (as determined by the Investigator);
• History of GI surgery within 3 months of diagnosis of acute diverticulitis;
• History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
• If female patient, active or recent history of endometriosis or dysmenorrhea;
• Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;