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Asacol in Acute Diverticulitis
NCT00554099Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2007
- Primary completion
- Mar 2010
- Countries
- 1
- Sponsor
- Warner Chilcott
- Modality
- Small Molecules
- Drugs
- Salcrozine
- Conditions
- diverticulitis
01
Overview
Phase 2, randomised, double-blind trial of Salcrozine in diverticulitis (3 arms), sponsored by Warner Chilcott. Primary endpoint: Global Symptom Score at 12 weeks. Started Nov 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Antibiotics + Placebo Mesalamine (Weeks 0-2) -> Placebo Mesalamine + Placebo Probiotic (Weeks 2-12)
Mesalamine
Antibiotics + Mesalamine (Weeks 0-2) -> Mesalamine + Placebo Probiotic (Weeks 2-12)
Mesalamine & Probiotic
Antibiotics + Mesalamine (Weeks 0-2) -> Mesalamine + Probiotic (Weeks 2-12)
03
Who it enrols
Adult patients with a clinical diagnosis of acute diverticulitis. Females must be postmenopausal, surgically sterile, or using acceptable contraception. Excludes patients with diverticular complications (fistula, abscess, obstruction, stenosis), active/recent peptic ulcer, IBS, major abdominal surgery, recent GI surgery, or HIV/AIDS.
04
Endpoints
Primary
Global Symptom Score
Secondary
Percentage of Responders
Change in Global Symptom Score
Withdrawal Due to Surgery for Diverticulitis
Recurrent Diverticulitis
05
Results
Not all primary endpoints met
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