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Propyphenazone + codeine versus propyphenazone for acute biliary or urogenital pain
2004-001069-17Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2005
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- biliary colicUrogenital pain
01
Overview
Phase 4, randomised, double-blind trial in biliary colic and Urogenital pain comparing Propyphenazone + codeine combination with Propyphenazone monotherapy (2 arms). Primary endpoint: AUC of pain intensity from 1 to 5 hours after drug application. Started Jan 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Propyphenazone + codeine combination
Combination suppository therapy with propyphenazone and codeine phosphate.
Propyphenazone monotherapy
Active-control suppository therapy with propyphenazone alone.
03
Who it enrols
Adults aged 18 years or older with acute, at least moderate to severe biliary or urogenital pain (VAS > 60 mm); pregnant or breastfeeding patients were excluded.
04
Endpoints
Primary
AUC of pain intensity from 1 to 5 hours after drug application
Secondary
Rescue medication use
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