NCT00891683

Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Aegera Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability data from these studies support further clinical development of AEG33773. The current study is proposed as a proof-of-concept study to assess the potential analgesic efficacy of AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.

Detailed description

Doses of AEG33773 selected for evaluation in this study provide a dose range (i.e., 100-400 mg) that may potentially include both a minimally effective dose and a maximum tolerated dose. Doses up to 400 mg were well tolerated in single- and multiple-dose Phase 1 studies. Before initiation of treatment with study drug, other analgesic medications will be discontinued during a 7-day Washout Period, and neuropathic pain will be assessed (in the absence of analgesic medication) over the next 3 days (Pain Assessment Period). Pain intensity level during these 3 days will be recorded daily, and only those subjects who meet predefined pain intensity threshold criteria on all 3 days will be eligible to receive study drug. Because pain may increase after analgesic medications have been discontinued, the combined length of the Washout and Pain Assessment Periods is limited in order that subjects who experience increased pain during this time may begin treatment with study drug without undue delay. This design will allow for adequate Baseline pain assessment over 3 days while avoiding a more prolonged period of increasing pain in the absence of analgesic medications.

Conditions

• Diabetic Peripheral Neuropathy
• Chronic Pain

Interventions

Type	Name	Description
DRUG	AEG33773 oral dosing	AEG33773 capsules: subjects will receive a daily dose of either 100 mg, 200 mg, or 400 mg AEG33773. Placebo capsules: subjects will receive a daily dose of placebo (matching test product). Capsules will be taken by mouth, over 28 consecutive days

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2009-05-01
• Last updated: 2010-05-31

Locations

20 sites across 4 countries: United States, Bulgaria, Canada, Romania