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Single Dose Analgesic Therapy in Painful Diabetic Neuropathy
NCT00837941Phase 2
Key facts
- Status
- Withdrawn
- Start
- Apr 2009
- Primary completion
- Aug 2009
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- pregabalinduloxetine
- Conditions
- diabetic neuropathy
01
Overview
Phase 2, randomised, double-blind trial of pregabalin and duloxetine in diabetic neuropathy (6 arms), sponsored by Merck & Co. Primary endpoint: Analgesic efficacy measured by patients self reported pain level. Planned start Apr 2009; status: withdrawn.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Sequence 1
Pregabalin -> Duloxetine -> Diphenhydramine
Sequence 2
Duloxetine -> Pregabalin -> Diphenhydramine
Sequence 3
Diphenhydramine -> Duloxetine -> Pregabalin
Sequence 4
Pregabalin -> Diphenhydramine -> Duloxetine
Sequence 5
Duloxetine -> Diphenhydramine -> Pregabalin
Sequence 6
Diphenhydramine -> Pregabalin -> Duloxetine
03
Who it enrols
Patients with type 1 or 2 diabetes and painful diabetic neuropathy in both feet, not on chronic pain therapy or on a stable dose. Excludes patients with CHF, seizure disorder, history of malignancy, Hepatitis B/C or HIV, or those who have failed 3 or more neuropathic pain drugs.
04
Endpoints
Primary
Analgesic efficacy measured by patients self reported pain level
Secondary
The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo
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