PainPhase 2NCT00115752
Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain
A Phase 2 study testing Valdecoxib and COX Inhibitor in people with Pain, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for… Read more about this study
- Who is it for?
- Ages 7 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Valdecoxib and COX Inhibitor
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2005to 4 Oct 2006
- Phase
- Phase 2
- 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 7 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female volunteers referred for third molar extraction willing to undergo 2 visits: 1 test and blood withdrawal visit and 1 surgical appointment
- Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars)
- In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation)
- Willing to undergo observation period for up to 6 hours postoperatively (3 hours post-surgery and 3 hours post-medication)
- Ability to complete a 100 mm VAS and a category scale every 20 minutes for the observation period (6 hours)
- Willing to have a microdialysis probe placed beneath the surgical flap during the 3 hours post-surgery and 3 hours post-medication
Show all 11Show fewer
- Willing to have a preoperative and postoperative biopsy at 3 hours after the surgery
- Must have two lower partial (rating = 3) or fully impacted (rating = 4) wisdom teeth (mandibular third molars)
- As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels
- As assessed at the screening visit, subjects must have specific ethnic background of interest to minimize the ethnic effect on pain sensitivity, genotype frequency and haplotype patterns.
- As assessed at the genotyping, subjects must have specific genotype of interest
Who cannot join
- Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics
- Patients who have had asthma, or hives
- Patients who are pregnant or nursing
- Patients with history of peptic ulcers and/or GI bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Nursing Research (NINR)
Bethesda, Maryland, 20892
About this study
This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription.
Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study.
Read more
Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced.
During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery.
Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising.
Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.
Read the detailed description
The proposed clinical trial will evaluate the role of genetic factors including single nucleotide polymorphisms from cyclooxygenase (COX) - 2 gene on acute pain after tissue injury and the analgesic effect of a COX inhibitor. Patients will be healthy volunteers scheduled for the surgical removal of impacted third molars. Genotyping will be performed before surgery and patients stratified to treatment with a COX inhibitor in this protocol or to other protocols examining different polymorphisms.
Under local anesthesia, 2 mandibular third molars will be removed. Microdialysis sampling in the extraction socket will be performed with pre- and post-surgical biopsies. Patients will receive a COX inhibitor as an analgesic drug for the post-operative pain. Outcomes evaluated will include clinical pain response, gene expression profile using microarray and quantitation of related proteins after oral surgery and the interaction of these factors with analgesia by a COX inhibitor. By studying these responses in patient samples for each genotype (non-variant homozygote, heterozygote and variant homozygote) from the COX-2 gene, we will attempt to replicate and extend previous findings on the role of genetic factors in the inflammatory process, clinical pain and variation in response to analgesic drugs.
- Conditions
- Pain
- Being tested
- Valdecoxib, COX Inhibitor
- Keywords
- Single Nucleotide Polymorphism, Analgesic Efficacy, Oral Surgery Model, Cyclooxygenase Inhibitor, Gene Expression Profile, Wisdom Teeth, Third Molar Extraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValdecoxibDrug
COX InhibitorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pain response.
Secondary outcomes (1)
Gene expression profiles using microarray and quantitation of related proteins after oral surgery and the interaction of these factors with analesia by a COX inhibitor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2005 (estimated)
- Study start20 Jun 2005
- Study completion4 Oct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115752
- Sponsor's protocol ID
- 050176
- Other IDs
- 05-NR-0176
- Status last verified
- 4 Oct 2006
- First submitted
- 23 Jun 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gordon SM, Brahim JS, Dubner R, McCullagh LM, Sang C, Dionne RA. Attenuation of pain in a randomized trial by suppression of peripheral nociceptive activity in the immediate postoperative period. Anesth Analg. 2002 Nov;95(5):1351-7, table of contents. doi: 10.1097/00000539-200211000-00047.
PubMed 12401625
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain
- ClinicalTrials.gov ID
- NCT00115752
- Acronym / sponsor ID
- 050176
- Conditions
- Pain
- Keywords
- Single Nucleotide Polymorphism, Analgesic Efficacy, Oral Surgery Model, Cyclooxygenase Inhibitor, Gene Expression Profile, Wisdom Teeth, Third Molar Extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 20 Jun 2005
- Study completion
- 4 Oct 2006
- First posted
- 24 Jun 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.
This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription.
Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study.
Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced.
During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery.
Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising.
Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.
Detailed description
The proposed clinical trial will evaluate the role of genetic factors including single nucleotide polymorphisms from cyclooxygenase (COX) - 2 gene on acute pain after tissue injury and the analgesic effect of a COX inhibitor. Patients will be healthy volunteers scheduled for the surgical removal of impacted third molars. Genotyping will be performed before surgery and patients stratified to treatment with a COX inhibitor in this protocol or to other protocols examining different polymorphisms.
Under local anesthesia, 2 mandibular third molars will be removed. Microdialysis sampling in the extraction socket will be performed with pre- and post-surgical biopsies. Patients will receive a COX inhibitor as an analgesic drug for the post-operative pain. Outcomes evaluated will include clinical pain response, gene expression profile using microarray and quantitation of related proteins after oral surgery and the interaction of these factors with analgesia by a COX inhibitor. By studying these responses in patient samples for each genotype (non-variant homozygote, heterozygote and variant homozygote) from the COX-2 gene, we will attempt to replicate and extend previous findings on the role of genetic factors in the inflammatory process, clinical pain and variation in response to analgesic drugs.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Male or female volunteers referred for third molar extraction willing to undergo 2 visits: 1 test and blood withdrawal visit and 1 surgical appointment
- Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars)
- In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation)
- Willing to undergo observation period for up to 6 hours postoperatively (3 hours post-surgery and 3 hours post-medication)
- Ability to complete a 100 mm VAS and a category scale every 20 minutes for the observation period (6 hours)
Key exclusion criteria (4 listed)
- Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics
- Patients who have had asthma, or hives
- Patients who are pregnant or nursing
- Patients with history of peptic ulcers and/or GI bleeding
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 | – |
| COX Inhibitor | Drug | – |
Primary outcome
Clinical pain response.
1 secondary outcome
Gene expression profiles using microarray and quantitation of related proteins after oral surgery and the interaction of these factors with analesia by a COX inhibitor.
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 2 Jul 2017.
- Background: PubMed 12401625Gordon SM, Brahim JS, Dubner R, McCullagh LM, Sang C, Dionne RA. Attenuation of pain in a randomized trial by suppression of peripheral nociceptive activity in the immediate postoperative period. Anesth Analg. 2002 Nov;95(5):1351-7, table of contents. doi: 10.1097/00000539-200211000-00047.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valdecoxib and COX Inhibitor in people with Pain, run by National Institute of Nursing Research (NINR) 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 11 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 2 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical pain response.. 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 NCT00115752, which also lists 1 linked publication.
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 2 Jul 2017.