PainPhase 1NCT01097902
Study of Experimental Models of Pain and Inflammation.
A Phase 1 study testing Ibuprofen in people with Pain and Inflammation, run by Martin Angst at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
- Conditions
- Pain, Inflammation
- Being tested
- Ibuprofen, Placebo tablet
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Ibuprofen, generic
800 mg oral one time only
Placebo tabletDrug
Also called Placebo
Placebo tablet oral one time only
| Study group | Role | What they receive |
|---|---|---|
| Ibuprophen 800 mg | Active comparator | 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. Receives: Drug: Ibuprofen |
| Placebo | Placebo comparator | Oral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation. Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.
Measured: 48 hours
Secondary outcomes (1)
Interleukin-1beta and Interleukin-8 regulation
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Angst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Angst, Stanford University
- Investigators
- Martin S Angst, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097902
- Sponsor's protocol ID
- SU-03012010-5102
- Status last verified
- Jun 2013
- First submitted
- 31 Mar 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
Publications
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.
PubMed 18396374Angst 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.
PubMed 19229167
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Inflammatory and Micro-incisional Pain Model Analysis by Gene Expression and Interstitial Fluid Proteomics of Skin Tissue
- ClinicalTrials.gov ID
- NCT01097902
- Acronym / sponsor ID
- SU-03012010-5102
- Conditions
- Pain, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Martin AngstUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprophen 800 mg | Active comparator | Drug: IbuprofenOral 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. |
| Placebo | Placebo comparator | Drug: Placebo tabletOral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Ibuprofen, generic800 mg oral one time only | Drug | Ibuprophen 800 mg |
| Placebo tabletAlso: PlaceboPlacebo tablet oral one time only | Drug | Placebo |
Primary outcome
Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.
Time frame: 48 hours
1 secondary outcome
Interleukin-1beta and Interleukin-8 regulation
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Background: PubMed 18396374Angst 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.
- Background: PubMed 19229167Angst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin S Angst principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen in people with Pain and Inflammation, run by Martin Angst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097902, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.