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Metronidazole and Ciprofloxacin in Colonic Crohn's Disease (MACINTOCC)
NCT00257699Phase 2
Key facts
- Status
- Terminated
- Start
- May 2006
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- Mount Sinai Hospital
- Modality
- Small Molecules
- Conditions
- Crohn's disease
01
Overview
Phase 2, randomised, double-blind trial in Crohn's disease comparing Placebo with Metronidazole + Ciprofloxacin (2 arms). Primary endpoint: Complete response to therapy defined as a reduction of the CDAI score to below 150 points with a reduction of at least 70 points from baseline at 8 weeks. Started May 2006; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Metronidazole placebo and Ciprofloxacin placebo
Metronidazole + Ciprofloxacin
Ciprofloxacin 500 mg bid + Metronidazole (dose based on weight: 250mg bid to 500mg bid)
03
Who it enrols
Patients 16 years or older with active Crohn's disease of the colon (CDAI 220-450) diagnosed for >1 month. Excludes pregnant/breastfeeding women, those with specific recent antibiotic/steroid/immunomodulator use, stool pathogens, C. difficile, or significant GI complications/resections.
04
Endpoints
Primary
Complete response to therapy defined as a reduction of the CDAI score to below 150 points with a reduction of at least 70 points from baseline
Secondary
Partial response (improvement) defined as a reduction of the CDAI score by 70 points or more but with a final value of 150 points or greater
Adverse event rates
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