Asacol Acute Diverticulitis(DIVA)Study

Official Title: “A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of a 12 Week Treatment of Acute Diverticulitis With Asacol® 2.4 g/Day (400 mg Mesalamine Tablet), Followed by a 9 Month Treatment-free Observation Period”

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.

Intervention(s) in this Clinical Trial

• Drug: Mesalamine
  • 6 - 400 mg tablets once daily
• Drug: Probiotic
  • Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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

Primary Measures

• Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
  • Time Frame: 12 Weeks
    Safety Issue?: No

Secondary Measures

• Percentage of Responders at Week 12 - ITT Population
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Percentage of Responders at Week 52 - ITT Population
  • Time Frame: 52 Weeks
    Safety Issue?: No
• Change in GSS From Baseline to Week 12 - ITT Population
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Change in GSS From Baseline to Week 52 - ITT Population
  • Time Frame: Baseline to Week 52
    Safety Issue?: No
• Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Recurrent Diverticulitis, Percentage, ITT Population, Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Recurrent Diverticulitis, Percentage, ITT Population, Week 52
  • Time Frame: 52 Weeks
    Safety Issue?: No

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;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Ana Balske, MD, PhD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00554099

Study ID Number: 2007020

ClinicalTrials.gov Identifier: NCT00554099

Health Authority: United States: Food and Drug Administration