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KETADOL: Ketamine for Refractory Cancer Pain
NCT00484484Phase 3
Key facts
- Status
- Completed
- Start
- May 2007
- Primary completion
- Sep 2009
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- ketamine
- Conditions
- cancer pain
01
Overview
Phase 3, randomised, double-blind trial in cancer pain comparing Ketamine + Opioids with Placebo + Opioids (2 arms). Primary endpoint: Daily pain score on an 11-point numerical pain rating scale at 4 days. Started May 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ketamine + Opioids
Opioids and ketamine
Placebo + Opioids
Opioids and placebo
03
Who it enrols
Hospitalised cancer patients with refractory pain on opioids.
04
Endpoints
Primary
Daily pain score on an 11-point numerical pain rating scale
Secondary
Patient Global Impression of Change
Clinical Global Impression of Change
Daily sleep interference score
Patient satisfaction of pain relief
Opioids consumption
Adverse effects of ketamine-opioids association
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