Asacol Acute Diverticulitis(DIVA)Study

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 Overview

• Status: Completed
• Conditions: Diverticulitis
• Intervention / Treatment: Drug: Placebo; Other: Dietary Advice; Drug: Antibiotic for Diverticulitis; Drug: Mesalamine; Drug: Probiotic

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Dietary Advice; Dietary advice; Drug: Antibiotic for Diverticulitis; Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.; Drug: Mesalamine; 6 - 400 mg tablets once 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	Other: Dietary Advice; Dietary advice; Drug: Antibiotic for Diverticulitis; Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.; Drug: Probiotic; Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days); Other Names: Align

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12		12 Weeks
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
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

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Ana Balske, MD, PhD, Procter and Gamble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 2, 2007
• First Submitted That Met QC Criteria: November 5, 2007
• First Posted (Estimate): November 6, 2007

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Bacterial Agents; Mesalamine
• Other Study ID Numbers: 2007020