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Asacol Acute Diverticulitis(DIVA)Study

Primary Purpose

Diverticulitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mesalamine
Probiotic
Placebo
Dietary Advice
Antibiotic for Diverticulitis
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulitis

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Mesalamine

Mesalamine & Probiotic

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
Recurrent Diverticulitis, Percentage, ITT Population, Week 12
At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).
Recurrent Diverticulitis, Percentage, ITT Population, Week 52
At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

Full Information

First Posted
November 2, 2007
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00554099
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Mesalamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mesalamine & Probiotic
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
6 - 400 mg tablets once daily
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
Align
Intervention Description
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.
Intervention Type
Other
Intervention Name(s)
Dietary Advice
Intervention Description
Dietary advice
Intervention Type
Drug
Intervention Name(s)
Antibiotic for Diverticulitis
Intervention Description
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Primary Outcome Measure Information:
Title
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
Description
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).
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Responders at Week 12 - ITT Population
Description
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).
Time Frame
12 Weeks
Title
Percentage of Responders at Week 52 - ITT Population
Description
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).
Time Frame
52 Weeks
Title
Change in GSS From Baseline to Week 12 - ITT Population
Description
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).
Time Frame
Baseline to Week 12
Title
Change in GSS From Baseline to Week 52 - ITT Population
Description
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).
Time Frame
Baseline to Week 52
Title
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
Time Frame
12 Weeks
Title
Recurrent Diverticulitis, Percentage, ITT Population, Week 12
Description
At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).
Time Frame
12 Weeks
Title
Recurrent Diverticulitis, Percentage, ITT Population, Week 52
Description
At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Balske, MD, PhD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Facility
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Merced
State/Province
California
Country
United States
Facility Name
Research Site
City
Oakland
State/Province
California
Country
United States
Facility Name
Research Facility
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Research Site
City
Pasadena
State/Province
California
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Littleton
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonsville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Research Facility
City
Zephyrhills
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pratt
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Monroe
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Research Site
City
Mexico
State/Province
Missouri
Country
United States
Facility Name
Research Facility
City
Cedar Knolls
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Site
City
Lake Success
State/Province
New York
Country
United States
Facility Name
Research Site
City
Setauket
State/Province
New York
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Research Facility
City
Harrisburg
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Morganton
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cranston
State/Province
Rhode Island
Country
United States
Facility Name
Research Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Odessa
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Research Facility
City
Monroe
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23426454
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.
Results Reference
derived

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Asacol Acute Diverticulitis(DIVA)Study

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