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

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ClinicalTrials.gov Identifier: NCT00832546
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : January 30, 2009
Sponsor:
Information provided by:
TorreyPines Therapeutics

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
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)




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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

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

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 Posted: January 30, 2009    Key Record Dates
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