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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders

ClinicalTrials.gov processed this record on November 25, 2014