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

This study has been completed.
Sponsor:
Information provided by:
TorreyPines Therapeutics
ClinicalTrials.gov Identifier:
NCT00832546
First received: January 28, 2009
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Healthy
Hyperalgesia
Drug: Placebo
Drug: Oral NGX426 (Powder in solution)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled, Cross-Over, Safety Tolerance and Experimental Hyperalgesia Study of Oral NGX426 in Healthy Male Volunteers

Further study details as provided by TorreyPines Therapeutics:

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Experimental: 2
Powder in solution
Drug: Oral NGX426 (Powder in solution)
Experimental: 3 Drug: Oral NGX426 (Powder in solution)

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males, age 21-55

Exclusion Criteria:

  • Allergy to study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832546

Locations
United States, California
University of California
San Diego, California, United States, 92037
Sponsors and Collaborators
TorreyPines Therapeutics
Investigators
Principal Investigator: Mark Wallace, M.D. University of California, San Diego
  More Information

No publications provided

Responsible Party: Susan Mellberg, R.N., M.B.A.; VP, Project Management, TorreyPines Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00832546     History of Changes
Other Study ID Numbers: NGX426CLP1003
Study First Received: January 28, 2009
Last Updated: January 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014