Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Modafinil for Opioid Induced Sedation
NCT00267332Phase 3
Key facts
- Status
- Terminated
- Start
- Jan 2006
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Small Molecules
- Drugs
- modafinil
01
Overview
Phase 3, randomised, double-blind trial comparing Modafinil with Placebo (2 arms). Primary endpoints: Epworth Sleepiness Scale and Pain. Started Jan 2006; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Modafinil
Modafinil 400mg
Placebo
Placebo
03
Who it enrols
Inclusion: Epworth Sleepiness Scale > 10; Etiology of sleepiness attributed only to opioids; Taking opioid for > 2 weeks or stable dose for > 1 week. Exclusion: MMSE < 25; Renal impairment (CrCl < 40); Hepatic dysfunction; History of cardiovascular disease.
04
Endpoints
Primary
Epworth Sleepiness Scale
Pain
Secondary
Frequency and severity of toxicity
Beyond the preview
Go deeper on NCT00267332.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00267332.