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Phase 2 N=117 Randomized Triple-blind Treatment

Asacol Acute Diverticulitis(DIVA)Study

Diverticulitis

Enrolled (actual)
117
Serious AEs
9.4%
Results posted
Jun 2011
Primary outcome: Primary: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population — 7.3; 4.4; 5.9 Scores on a Scale — p=0.3781

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Mesalamine (Drug); Probiotic (Drug); Placebo (Drug); Dietary Advice (Other); Antibiotic for Diverticulitis (Drug)
Age
Adult, Older Adult · 35+ yrs
Sex
All
Sponsor
Warner Chilcott
Primary completion
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population
7.3; 4.4; 5.9 0.3781
SECONDARY
Percentage of Responders at Week 12 - ITT Population
41.4; 62.5; 48.1 0.0576
SECONDARY
Percentage of Responders at Week 52 - ITT Population
50.0; 66.7; 29.2 0.1266
SECONDARY
Change in GSS From Baseline to Week 12 - ITT Population
-16.14; -17.63; -16.11 0.3082
SECONDARY
Change in GSS From Baseline to Week 52 - ITT Population
-16.82; -17.30; -16.00 0.4448
SECONDARY
Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12
2.4; 5.0; 0.0 0.7165
SECONDARY
Recurrent Diverticulitis, Percentage, ITT Population, Week 12
20.0; 12.5; 11.8 0.1907
SECONDARY
Recurrent Diverticulitis, Percentage, ITT Population, Week 52
31.0; 28.1; 37.0 0.3983

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.

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;
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00554099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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