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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Warner Chilcott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Antibiotics, Antitubercular
Mesalamine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
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 July 29, 2014