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  

Information obtained from ClinicalTrials.gov on July 02, 2009

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