Phase 2
N=117
Asacol Acute Diverticulitis(DIVA)Study
Diverticulitis
Bottom Line
View on ClinicalTrials.gov: NCT00554099 ↗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
| Outcome | Result | p-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;
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.