Asacol Acute Diverticulitis(DIVA)Study

Phase 2

Completed

Conditions: Diverticulitis

Interventions: Drug: Placebo
Drug: Probiotic
Drug: Mesalamine
Other: Dietary Advice
Drug: Antibiotic for Diverticulitis

Registration Number: NCT00554099

Lead Sponsor: Warner Chilcott

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 117

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;

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Placebo	Dietary Advice	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.
Placebo	Antibiotic for Diverticulitis	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.
Mesalamine	Dietary Advice	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.
Mesalamine	Antibiotic for Diverticulitis	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.
Mesalamine & Probiotic	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
Mesalamine & Probiotic	Dietary Advice	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
Mesalamine & Probiotic	Antibiotic for Diverticulitis	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
Mesalamine	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.

Primary Outcome Measures

Name	Time	Method
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population	12 Weeks	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders at Week 12 - ITT Population	12 Weeks	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	52 Weeks	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	Baseline to Week 12	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	Baseline to Week 52	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	12 Weeks
Recurrent Diverticulitis, Percentage, ITT Population, Week 12	12 Weeks	At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).
Recurrent Diverticulitis, Percentage, ITT Population, Week 52	52 Weeks	At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).