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| Sponsor: | EpiCept Corporation |
|---|---|
| Information provided by: | EpiCept Corporation |
| ClinicalTrials.gov Identifier: | NCT00475904 |
Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Post Herpetic Neuralgia PHN Neuropathy Nerve Pain |
Drug: EpiCept-NP-1 Cream Drug: Gabapentin Capsules Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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) |
| Enrollment: | 360 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
amitriptyline 4% ketamine 2% cream, placebo capsules: Active Comparator
Np-1 cream and placebo gabapentin
|
Drug: EpiCept-NP-1 Cream
ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
|
|
gabapentin capsules, placebo cream: Active Comparator
gabapentin caps and placebo cream
|
Drug: Gabapentin Capsules
1800mg/day capsules for 4 weeks
|
|
placebo cream and capsules: Placebo Comparator
placebo cream and capsules
|
Drug: placebo
placebo cream and caps
|
This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | EpiCept Corporation ( Stephane Allard, Chief Medical Officer ) |
| Study ID Numbers: | EPC2007-02 |
| Study First Received: | May 17, 2007 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00475904 History of Changes |
| Health Authority: | United States: Food and Drug Administration; India: Ministry of Health |
|
Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Topical |
|
Neuralgia, Postherpetic Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Neuromuscular Diseases Sensory System Agents |
Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Neuralgia Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Peripheral Nervous System Diseases Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |
