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

This study has been completed.

First Received: January 28, 2009 Last Updated: January 29, 2009 History of Changes

Sponsored by:	TorreyPines Therapeutics
Information provided by:	TorreyPines Therapeutics
ClinicalTrials.gov Identifier:	NCT00832546

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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
1: Placebo Comparator Placebo	Drug: Placebo
2: Experimental Powder in solution	Drug: Oral NGX426 (Powder in solution)
3: Experimental	Drug: Oral NGX426 (Powder in solution)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Somatosensory Disorders

Neurologic Manifestations
Healthy
Hyperalgesia

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Somatosensory Disorders

Nervous System Diseases
Neurologic Manifestations
Hyperalgesia

ClinicalTrials.gov processed this record on August 28, 2009