NCT00475904

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 6, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

May 17, 2007

Results QC Date

April 20, 2011

Last Update Submit

July 25, 2011

Conditions

Post Herpetic NeuralgiaPHNNeuropathyNerve Pain

Keywords

Post Herpetic NeuralgiaPHNNeuropathyNerve PainTopical

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline and 28 days

  • Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin

    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.

    baseline to 28 Days

Study Arms (3)

amitriptyline 4% ketamine 2% cream, placebo capsules

ACTIVE COMPARATOR

Np-1 cream and placebo gabapentin

Drug: EpiCept-NP-1 Cream

gabapentin capsules, placebo cream

ACTIVE COMPARATOR

gabapentin caps and placebo cream

Drug: Gabapentin Capsules

placebo cream and capsules

PLACEBO COMPARATOR

placebo cream and capsules

Drug: placebo

Interventions

EpiCept-NP-1 CreamDRUG

ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks

amitriptyline 4% ketamine 2% cream, placebo capsules
Gabapentin CapsulesDRUG

1800mg/day capsules for 4 weeks

Also known as: gabapentin, neurontin
gabapentin capsules, placebo cream
placeboDRUG

placebo cream and caps

Also known as: vehicle cream, placebo capsules
placebo cream and capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

You may not qualify if:

  • Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple Centers

New Delhi, 110016, India

Location

MeSH Terms

Conditions

Neuralgia, PostherpeticNeuralgia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
EpiCept Corporation
sallard@epicept.com
914-606-3500

Study Officials

  • Robert H Dworkin, Ph.D.

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 27, 2011

Results First Posted

July 6, 2011

Record last verified: 2011-07

Locations

IN(1)