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Asacol Acute Diverticulitis(DIVA)Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00554099
First received: November 2, 2007
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diverticulitis
 Drug: Mesalamine
Drug: Probiotic
Drug: Placebo
Other: Dietary Advice
Drug: Antibiotic for Diverticulitis
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Global Symptom Score (GSS) at Week 12, Primary Efficacy Population [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Recurrent Diverticulitis, Percentage, ITT Population, Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).

  • Recurrent Diverticulitis, Percentage, ITT Population, Week 52 [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).


Enrollment: 117
Study Start Date: November 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Mesalamine
6 - 400 mg tablets once 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.
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
 Drug: Probiotic
Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)
Other Name: Align
Other: Dietary Advice
Dietary advice
Drug: Antibiotic for Diverticulitis
Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

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

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554099

  Show 36 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Ana Balske, MD, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00554099     History of Changes
Other Study ID Numbers: 2007020
Study First Received: November 2, 2007
Results First Received: March 14, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Mesalamine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013