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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00832546
First Posted: January 30, 2009
Last Update Posted: January 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
TorreyPines Therapeutics
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 28, 2009
First Posted: January 30, 2009
Last Update Posted: January 30, 2009
Last Verified: January 2009

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