Clinical trial NCT00554099: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diverticulitis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-11-06
Enrollment: 117
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percentage of Responders at Week 12 - ITT Population
timeFrame: 12 Weeks
measure: Percentage of Responders at Week 52 - ITT Population
timeFrame: 52 Weeks
measure: Change in GSS From Baseline to Week 12 - ITT Population
timeFrame: Baseline to Week 12
measure: Change in GSS From Baseline to Week 52 - ITT Population
timeFrame: Baseline to Week 52
measure: Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
timeFrame: 12 Weeks
measure: Recurrent Diverticulitis, Percentage, ITT Population, Week 12
timeFrame: 12 Weeks
measure: Recurrent Diverticulitis, Percentage, ITT Population, Week 52
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Facility
state: California
city: Merced
country: United States
facility: Research Site
state: California
city: Oakland
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Facility
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Lafayette
country: United States
facility: Research Site
state: Colorado
city: Littleton
country: United States
facility: Research Site
state: Colorado
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Jacksonsville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Zephyrhills
country: United States
facility: Research Facility
state: Florida
city: Pratt
country: United States
facility: Research Site
state: Kansas
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Chesterfield
country: United States
facility: Research Site
state: Michigan
city: Tupelo
country: United States
facility: Research Site
state: Mississippi
city: Mexico
country: United States
facility: Research Site
state: Missouri
city: Cedar Knolls
country: United States
facility: Research Facility
state: New Jersey
city: Great Neck
country: United States
facility: Research Site
state: New York
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Setauket
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Harrisburg
country: United States
facility: Research Facility
state: North Carolina
city: Morganton
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cranston
country: United States
facility: Research Site
state: Rhode Island
city: Longview
country: United States
facility: Research Site
state: Texas
city: Odessa
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Monroe
country: United States
facility: Research Facility
state: Wisconsin
Study officials:
affiliation: Procter and Gamble
name: Ana Balske, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Stollman N, Magowan S, Shanahan F, Quigley EM; DIVA Investigator Group. A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial. J Clin Gastroenterol. 2013 Aug;47(7):621-9. doi: 10.1097/MCG.0b013e31828003f6.