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Intra-anal Nifedipine for Chronic Anal Fissure
NCT02527109Phase 3
Key facts
- Status
- Completed
- Start
- May 2016
- Primary completion
- Jun 2018
- Countries
- 4
- Sponsor
- RDD Pharma
- Modality
- Small Molecules
- Drugs
- nifedipine
- Conditions
- chronic anal fissure (CAF)
01
Overview
Phase 3, randomised, double-blind trial of nifedipine in chronic anal fissure (CAF) (3 arms), sponsored by RDD Pharma. Primary endpoint: Rectal pain measured by VAS at 56 days. Started May 2016; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Nifedipine 24 mg/day
Nifedipine 12 mg BID
Nifedipine 12 mg/day
Nifedipine 12 mg OD (morning) + Placebo (evening)
Placebo
Placebo BID
03
Who it enrols
Adult patients with chronic anal fissure and significant rectal pain (VAS > 40mm), excluding those with IBD, HIV, Hepatitis, recent malignancy, or cardiovascular disease.
04
Endpoints
Primary
Rectal pain measured by VAS
Secondary
Healing of anal fissure
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