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Effect of Coated Phenylephrine Suppositories on Anal Pressure
NCT00972998Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2009
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- RDD Pharma
- Modality
- Small Molecules
- Drugs
- phenylephrine
- Conditions
- fecal incontinence (FI)
01
Overview
Phase 2, open-label, single-arm trial of phenylephrine in fecal incontinence (FI), sponsored by RDD Pharma. Primary endpoint: Change in Resting Anal Pressure from baseline at 8 hours. Started Sep 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Healthy individuals
Subjects receive Coated Phenylephrine suppositories. Dose escalation from 40mg to 80mg based on response.
03
Who it enrols
Healthy male or female subjects aged 18-55 without chronic diseases or recent use of anticoagulants/antiplatelets, and no rectal abnormalities.
04
Endpoints
Primary
Change in Resting Anal Pressure from baseline
Secondary
The ratio of change in anal pressure to plasma Phenylephrine level
The ratio of change in anal pressure to change in blood pressure
The ratio of change in anal pressure to change in heart rate
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