NCT00832546

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

January 28, 2009

Last Update Submit

January 29, 2009

Conditions

HealthyHyperalgesia

Study Arms (3)

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)

Interventions

PlaceboDRUG
1
Oral NGX426 (Powder in solution)DRUG
23

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males, age 21-55

You may not qualify if:

  • Allergy to study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

PowdersSolutions

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Mark Wallace, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 28, 2009

First Posted

January 30, 2009

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

US(1)