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Completed

NCT Number: NCT00554099

Asacol Acute Diverticulitis(DIVA)Study

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.

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Mesalamine

Drug

6 - 400 mg tablets once daily

Probiotic

Drug

Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days)

Other names: Align

Placebo

Drug

6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.

Dietary Advice

Other

Dietary advice

Antibiotic for Diverticulitis

Drug

Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.

Primary outcomes

  1. Global Symptom Score (GSS) at Week 12, Primary Efficacy Population

    Time frame: 12 Weeks

    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 outcomes

  1. Percentage of Responders at Week 12 - ITT Population

    Time frame: 12 Weeks

    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).

  2. Percentage of Responders at Week 52 - ITT Population

    Time frame: 52 Weeks

    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).

  3. Change in GSS From Baseline to Week 12 - ITT Population

    Time frame: Baseline to Week 12

    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).

  4. Change in GSS From Baseline to Week 52 - ITT Population

    Time frame: Baseline to Week 52

    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).

  5. Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12

    Time frame: 12 Weeks

  6. Recurrent Diverticulitis, Percentage, ITT Population, Week 12

    Time frame: 12 Weeks

    At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).

  7. Recurrent Diverticulitis, Percentage, ITT Population, Week 52

    Time frame: 52 Weeks

    At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2007
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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