Asacol Acute Diverticulitis(DIVA)Study

Diverticulitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554099
• Other study ID #: 2007020
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2007
• Last updated: April 15, 2013
• Start date: November 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Asheville	North Carolina
United States	Research Site	Boynton Beach	Florida
United States	Research Facility	Cedar Knolls	New Jersey
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Chesterfield	Michigan
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cranston	Rhode Island
United States	Research Site	Great Neck	New York
United States	Research Site	Greenville	North Carolina
United States	Research Facility	Harrisburg	North Carolina
United States	Research Site	Jacksonsville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Lafayette	Colorado
United States	Research Site	Lake Success	New York
United States	Research Site	Littleton	Colorado
United States	Research Site	Longview	Texas
United States	Research Facility	Los Angeles	California
United States	Research Site	Merced	California
United States	Research Site	Mexico	Missouri
United States	Research Facility	Monroe	Wisconsin
United States	Research Site	Monroe	Louisiana
United States	Research Site	Morganton	North Carolina
United States	Research Site	Oakland	California
United States	Research Site	Odessa	Texas
United States	Research Facility	Orange	California
United States	Research Site	Palm Springs	California
United States	Research Site	Pasadena	California
United States	Research Site	Pratt	Kansas
United States	Research Site	Setauket	New York
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Tucson	Arizona
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Facility	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 Weeks	No
Secondary	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).	12 Weeks	No
Secondary	Percentage of Responders at Week 52 - 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).	52 Weeks	No
Secondary	Change in GSS From Baseline to Week 12 - ITT 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).	Baseline to Week 12	No
Secondary	Change in GSS From Baseline to Week 52 - ITT 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).	Baseline to Week 52	No
Secondary	Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12		12 Weeks	No
Secondary	Recurrent Diverticulitis, Percentage, ITT Population, Week 12	At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).	12 Weeks	No
Secondary	Recurrent Diverticulitis, Percentage, ITT Population, Week 52	At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).	52 Weeks	No