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

January 29, 2009 updated by: TorreyPines Therapeutics

A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92037
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males, age 21-55

Exclusion Criteria:

  • Allergy to study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3
Drug: Oral NGX426 (Powder in solution)
Placebo Comparator: 1
Placebo
Drug: Placebo
Experimental: 2
Powder in solution
Drug: Oral NGX426 (Powder in solution)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TorreyPines Therapeutics

Investigators

  • Principal Investigator: Mark Wallace, M.D., University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGX426CLP1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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