Study of Experimental Models of Pain and Inflammation.

June 18, 2013 updated by: Martin Angst

Experimental Inflammatory and Micro-incisional Pain Model Analysis by Gene Expression and Interstitial Fluid Proteomics of Skin Tissue

The experimental pain model studied in this proposal show characteristics of an inflamed wound with a pro-inflammatory response. This study will help discover candidate genetic and/or proteomic pain biomarkers that could provide objective and mechanism based tests to diagnose, monitor or quantify pain. We also hope to determine the measurable effects of a known non-steroidal anti-inflammatory drug (NSAID) on biomarkers of pain and inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:1) Age 18-60 2) Skin type II or III according to classification of Fitzpatrick 3) Negative pregnancy test (women of childbearing potential) 4) Willing and able to sign an informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization and to comply with study procedures

Exclusion Criteria:1) History of acute or chronic illness that may hinder study procedures or confuse interpretation of the data (e.g. dermatological, neurological, psychiatric or addictive diseases) 2) Clinically significant cardiovascular, pulmonary, hepatic or renal diseases 3) Major bodily injury within 3 months of study participation 4) Surgery within 3 months of study participation 5) Pregnancy or breast-feeding 6) Intake of prescription drugs with anti/pro-inflammatory action 7) Intake of prescription drugs with anti/pro-analgesic action 8) Inability to abstain from any anti/pro inflammatory drugs during the 24-hour period preceding a study session 9) Inability to abstain from any anti/pro-analgesic drugs during the 24-hour period preceding a study session 10) Prior medical history that would contraindicate the use of NSAID, or previous negative reaction to NSAIDs or aspirin 11) Inability to obtain at least 6 hours of sleep during the night preceding a study session

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprophen 800 mg
Oral ibuprofen 800 mg, administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.
Drug: Ibuprofen
800 mg oral one time only
Other Names:
  • Ibuprofen, generic
Placebo Comparator: Placebo
Oral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.
Drug: Placebo tablet
Placebo tablet oral one time only
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Interleukin-1beta and Interleukin-8 regulation
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin Angst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-03012010-5102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Ibuprofen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe