A Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

NCT00475904 Phase 2 COMPLETED Results posted

The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

Details

Lead sponsor	EpiCept Corporation
Phase	Phase 2
Status	COMPLETED
Enrolment	360
Start date	2007-07
Completion	2008-06

Conditions

• Post Herpetic Neuralgia
• PHN
• Neuropathy
• Nerve Pain

Interventions

• EpiCept-NP-1 Cream
• Gabapentin Capsules
• placebo

Primary outcomes

• Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. — baseline and 28 days
  Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
• Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin — baseline to 28 Days
  Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.

Countries

India