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Neotrofin for Chemotherapy-Induced Peripheral Neuropathy
NCT00041795Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2002
- Countries
- 1
- Sponsor
- NeoTherapeutics, Inc.
- Modality
- Small Molecules
- Drugs
- leteprinim potassium
- Conditions
- chemotherapy-induced peripheral neuropathy (CIPN)
01
Overview
Phase 2, randomised, double-blind trial in chemotherapy-induced peripheral neuropathy (CIPN) comparing Neotrofin with Placebo (2 arms). Primary endpoints: Safety of Neotrofin and Efficacy of Neotrofin. Started Jan 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Neotrofin
Neotrofin treatment arm
Placebo
Placebo control arm
03
Who it enrols
Patients with cancer who have received chemotherapy resulting in sensory or motor neuropathy (>= Grade 2, or Grade 1 for multiple myeloma).
04
Endpoints
Primary
Safety of Neotrofin
Efficacy of Neotrofin
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