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A Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Voluneteers

NCT ID: NCT00832546

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine the effects of NGX426 on intradermal capsaicin induced pain in hyperalgesia.

Detailed Description

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Conditions

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Healthy Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2

Powder in solution

Group Type EXPERIMENTAL

Oral NGX426 (Powder in solution)

Intervention Type DRUG

3

Group Type EXPERIMENTAL

Oral NGX426 (Powder in solution)

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Oral NGX426 (Powder in solution)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males, age 21-55

Exclusion Criteria

* Allergy to study drug
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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TorreyPines Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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TorreyPines Therapeutics, Inc.

Principal Investigators

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Mark Wallace, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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NGX426CLP1003

Identifier Type: -

Identifier Source: org_study_id