PainPhase 4NCT00260325
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
A Phase 4 study testing valdecoxib in people with Pain and Hyperalgesia, run by Penn State University at 1 site in United States.
Trial summary
Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Hyperalgesia
- What is being tested?
- valdecoxib
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Apr 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male of non-pregnant female; 18yo or older
- not currently taking NSAID
- able and willing to provide informed consent
- willing to avoid other NSAIDs in 24 hour period following study
- no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin
Who cannot join
- pregnant or breast feeding
- use of NSAIDS or other analgesic medications in past 7 days
- unwilling or unable to give informed consent
- contraindication to any study medication or other NSAID
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.
- Conditions
- Pain, Hyperalgesia
- Being tested
- valdecoxib
- Keywords
- pretreatment, healthy volunteers
- Medical subject headings
- Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the area of secondary hyperalgesia
Secondary outcomes (2)
Reduction in pain threshold
Reduction in pain unpleasantness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startAug 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Piotr K Janicki, MD, PhD, Principal investigator, Penn State University, Dept of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260325
- Sponsor's protocol ID
- 70,328-01
- Other IDs
- IIG Pfizer(PJK), MOIRR10732
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2005
- Last updated
- 24 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00260325
- Acronym / sponsor ID
- 70,328-01
- Conditions
- Pain, Hyperalgesia
- Keywords
- pretreatment, healthy volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH)
- Study start
- Aug 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 1 Dec 2005 (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.
Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy male of non-pregnant female; 18yo or older
- not currently taking NSAID
- able and willing to provide informed consent
- willing to avoid other NSAIDs in 24 hour period following study
- no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin
Key exclusion criteria (4 listed)
- pregnant or breast feeding
- use of NSAIDS or other analgesic medications in past 7 days
- unwilling or unable to give informed consent
- contraindication to any study medication or other NSAID
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 |
|---|---|---|
| valdecoxib | Drug | – |
Primary outcome
Reduction in the area of secondary hyperalgesia
2 secondary outcomes
Reduction in pain threshold
Reduction in pain unpleasantness
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 24 Nov 2017.
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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.
Piotr K Janicki, MD, PhD principal investigator
Penn State University, Dept of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valdecoxib in people with Pain and Hyperalgesia, run by Penn State University 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?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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 24 Nov 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction in the area of secondary hyperalgesia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2017.