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Safety and ECG Effects of Propoxyphene Napsylate in Healthy Subjects
NCT01133873Phase 4
Key facts
- Status
- Terminated
- Start
- Jun 2010
- Primary completion
- Nov 2010
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- dextropropoxyphene
- Conditions
- pain
01
Overview
Phase 4, randomised, double-blind trial in pain comparing Propoxyphene napsylate with Placebo (2 arms). Primary endpoint: Safety and Tolerability at Day 13. Started Jun 2010; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Propoxyphene napsylate
100 mg capsules 6 times a day in ascending doses
Placebo
Placebo capsules 6 times a day in ascending doses
03
Who it enrols
Healthy adult subjects with BMI 18-30 kg/m2, no history of significant disease, substance abuse, or tobacco use within 6 months.
04
Endpoints
Primary
Safety and Tolerability
Secondary
Relationship between serum concentrations and cardiac conduction
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