Asacol Acute Diverticulitis(DIVA)Study

Warner Chilcott117 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

117

Conditions

Diverticulitis

Interventions

MesalamineDRUG

6 - 400 mg tablets once daily

ProbioticDRUG

Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)

PlaceboDRUG

6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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;

Locations (36)

Outcomes

Primary Outcomes

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population

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).

Time frame: 12 Weeks

Secondary Outcomes

Percentage of Responders at Week 12 - ITT Population

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).

Time frame: 12 Weeks

Percentage of Responders at Week 52 - ITT Population

Time frame: 52 Weeks

Change in GSS From Baseline to Week 12 - ITT Population

Data from ClinicalTrials.gov

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Research Site

Tucson, Arizona, United States

Research Facility

Los Angeles, California, United States

Research Site

Merced, California, United States

Research Site

Oakland, California, United States

Research Facility

Orange, California, United States

Research Site

Palm Springs, California, United States

Research Site

Pasadena, California, United States

Research Site

Lafayette, Colorado, United States

Research Site

Littleton, Colorado, United States

Research Site

Boynton Beach, Florida, United States

...and 26 more locations