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Diltiazem Hydrochloride Cream in Anal Fissure
NCT01217515Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Mar 2012
- Countries
- 6
- Sponsor
- SLA Pharma
- Modality
- Small Molecules
- Drugs
- DOLIZEM
- Conditions
- anal fissure
01
Overview
Phase 3, randomised, double-blind trial of DOLIZEM in anal fissure (3 arms), sponsored by SLA Pharma. Primary endpoint: Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation at 4 weeks. Started Oct 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Diltiazem 4%
Diltiazem hydrochloride 4% cream applied peri-anally three times daily.
Diltiazem 2%
Diltiazem hydrochloride 2% cream applied peri-anally three times daily.
Placebo
Placebo cream applied peri-anally three times daily.
03
Who it enrols
Adult patients with chronic anal fissure (>4 weeks duration) and significant pain (NRS >4), excluding those with other anal pathologies, IBD, HIV, or recent use of specific fissure treatments.
04
Endpoints
Primary
Change From Baseline in Average of Worst Anal Pain Associated With or Following Defaecation
Secondary
Patient's Global Impression of Improvement
Assessment of Adverse Events
Clinical Laboratory Results
Vital Signs
Sensitivity Reactions
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