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Study of Experimental Models of Pain and Inflammation.

Primary Purpose

Pain, Inflammation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ibuprofen

Placebo tablet

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ibuprophen 800 mg

Placebo

Arm Description

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.

Oral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.

Outcomes

Primary Outcome Measures

Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.

Secondary Outcome Measures

Interleukin-1beta and Interleukin-8 regulation

Full Information

NCT ID

NCT01097902

First Posted

March 31, 2010

Last Updated

June 18, 2013

Sponsor

Martin Angst

1. Study Identification

Unique Protocol Identification Number

NCT01097902

Brief Title

Study of Experimental Models of Pain and Inflammation.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Martin Angst

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Inflammation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibuprophen 800 mg

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Oral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Other Intervention Name(s)

Ibuprofen, generic

Intervention Description

800 mg oral one time only

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Other Intervention Name(s)

Placebo

Intervention Description

Placebo tablet oral one time only

Primary Outcome Measure Information:

Title

Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

Interleukin-1beta and Interleukin-8 regulation

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin S Angst

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18396374

Citation

Angst MS, Clark JD, Carvalho B, Tingle M, Schmelz M, Yeomans DC. Cytokine profile in human skin in response to experimental inflammation, noxious stimulation, and administration of a COX-inhibitor: a microdialysis study. Pain. 2008 Sep 30;139(1):15-27. doi: 10.1016/j.pain.2008.02.028. Epub 2008 Apr 8.

Results Reference

background

PubMed Identifier

19229167

Citation

Angst MS, Tingle M, Schmelz M, Carvalho B, Yeomans DC. Human in-vivo bioassay for the tissue-specific measurement of nociceptive and inflammatory mediators. J Vis Exp. 2008 Dec 1;(22):1074. doi: 10.3791/1074.

Results Reference

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Study of Experimental Models of Pain and Inflammation.

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