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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

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 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
• Other: placebo
  • 6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.
• Drug: Mesalamine and Align
  • 6 tablets once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of placebo plus standard care and dietary advice.
• Active Comparator: 2
  • 6 tablets(2.4 g/day) once a day of mesalamine and 1 capsule once a day of Align plus standard care and dietary advice.
• Placebo Comparator: 3
  • 6 tablets once a day of placebo and 1 capsule once a day of placebo plus standard care and dietary advice.

Primary Measures

• Primary Outcomes: effective in decreasing the gastrointestinal symptom severity in patients after an attack of diverticulitis
  • Time Frame: one year
    Safety Issue?: No

Secondary Measures

• Secondary Outcomes: assessments of surrogate markers during the treatment & non treatment period
  • Time Frame: one year
    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: 49 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Ana Balske, MD, PhD Study Director Procter and Gamble  

Overall Contact: Carl J Eastwood, MS 866-448-3009 eastwood.cj@pg.com

Information obtained from ClinicalTrials.gov on October 10, 2008

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