PainPhase 2NCT00001724
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
A Phase 2 study testing Flurbiprofen in people with Pain, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Flurbiprofen
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Nov 2001
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients of either sex requiring removal of two impacted mandibular third molars (partial bony or soft tissue impaction).
16 years of age of older.
Indicates willingness to undergo oral surgery with local anesthesia and intravenous midazolam only.
Willing to return for the removal of the remaining maxillary third molars at a second appointment.
Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be excluded.
Those with a history of aspirin or NSAID-induced asthma will be excluded.
Females of childbearing potential who are not practicing adequate contraception will be excluded.
Pregnant or nursing females will be excluded.
Patients with recent history or present signs of renal, hepatic, endocrine, pulmonary, cardiac, gastrointestinal, neurologic, or cerebral function impairment will be excluded.
Those with psychiatric disorders will be excluded.
Patients who have taken an investigational drug within 30 days of this study will be excluded.
Those who have taken another analgesic, steroid, opioid, or NSAID within 24 hours prior to the study will be excluded.
Those with an absence of bilateral local anesthesia during surgery as evidenced by anesthesia or paresthesia of the lower lip postoperatively will be excluded.
Patients who use drugs which will interact with NSAID such as aspirin, warfarin, probenecid, methotrexate, lithium and diuretics will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model
This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain.
Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study.
Read more
Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo.
All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
Read the detailed description
This study proposes to evaluate the analgesic efficacy, tissue response, and adverse effects of microencapsulated preparations of a nonsteroidal anti-inflammatory drug (NSAID) and a long-acting local anesthetic administered into post-extraction sites prior to pain onset. Subjects (N=84) will have two mandibular impacted third molars removed and be randomly allocated to receive one of six possible treatments placed into the sockets: 0 mg (placebo formulation), 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg flurbiprofen, or 50 mg bupivacaine. Each patient in these six groups (N=12/group) will also receive an oral placebo capsule. The seventh group of subjects will receive a placebo at the extraction sites and 25 mg of flurbiprofen orally. Subjects will remain at the clinic for six hours following drug administration to record every 30 minutes the offset of mandibular anesthesia, postoperative pain intensity, side effects, and for observation of recurrent bleeding. Demonstration of a dose-responsive relationship for flurbiprofen at doses lower than needed for analgesia following oral administration will provide the basis for a second study in which an optimal dose of flurbiprofen will be combined with bupivacaine.
- Conditions
- Pain
- Being tested
- Flurbiprofen
- Keywords
- Pain, Microencapsulated Drug, NSAID, Acute Inflammation, Peripheral Administration, Dose-Response, Relative Potency Assay, Pharmacokinetics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlurbiprofenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startNov 1997
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001724
- Sponsor's protocol ID
- 980035
- Other IDs
- 98-D-0035
- Status last verified
- Nov 2001
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Dionne RA. Suppression of dental pain by the preoperative administration of flurbiprofen. Am J Med. 1986 Mar 24;80(3A):41-9. doi: 10.1016/0002-9343(86)90110-5.
PubMed 3515923Moore UJ, Seymour RA, Rawlins MD. The efficacy of locally applied aspirin and acetaminophen in postoperative pain after third molar surgery. Clin Pharmacol Ther. 1992 Sep;52(3):292-6. doi: 10.1038/clpt.1992.144.
PubMed 1526087Allison MC, Howatson AG, Torrance CJ, Lee FD, Russell RI. Gastrointestinal damage associated with the use of nonsteroidal antiinflammatory drugs. N Engl J Med. 1992 Sep 10;327(11):749-54. doi: 10.1056/NEJM199209103271101.
PubMed 1501650
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model
- ClinicalTrials.gov ID
- NCT00001724
- Acronym / sponsor ID
- 980035
- Conditions
- Pain
- Keywords
- Pain, Microencapsulated Drug, NSAID, Acute Inflammation, Peripheral Administration, Dose-Response, Relative Potency Assay, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Nov 1997
- Study completion
- Nov 2001
- First posted
- 4 Nov 1999 (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 the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain.
Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study.
Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo.
All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
Detailed description
This study proposes to evaluate the analgesic efficacy, tissue response, and adverse effects of microencapsulated preparations of a nonsteroidal anti-inflammatory drug (NSAID) and a long-acting local anesthetic administered into post-extraction sites prior to pain onset. Subjects (N=84) will have two mandibular impacted third molars removed and be randomly allocated to receive one of six possible treatments placed into the sockets: 0 mg (placebo formulation), 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg flurbiprofen, or 50 mg bupivacaine. Each patient in these six groups (N=12/group) will also receive an oral placebo capsule. The seventh group of subjects will receive a placebo at the extraction sites and 25 mg of flurbiprofen orally. Subjects will remain at the clinic for six hours following drug administration to record every 30 minutes the offset of mandibular anesthesia, postoperative pain intensity, side effects, and for observation of recurrent bleeding. Demonstration of a dose-responsive relationship for flurbiprofen at doses lower than needed for analgesia following oral administration will provide the basis for a second study in which an optimal dose of flurbiprofen will be combined with bupivacaine.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 |
|---|---|---|
| Flurbiprofen | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3515923Dionne RA. Suppression of dental pain by the preoperative administration of flurbiprofen. Am J Med. 1986 Mar 24;80(3A):41-9. doi: 10.1016/0002-9343(86)90110-5.
- Background: PubMed 1526087Moore UJ, Seymour RA, Rawlins MD. The efficacy of locally applied aspirin and acetaminophen in postoperative pain after third molar surgery. Clin Pharmacol Ther. 1992 Sep;52(3):292-6. doi: 10.1038/clpt.1992.144.
- Background: PubMed 1501650Allison MC, Howatson AG, Torrance CJ, Lee FD, Russell RI. Gastrointestinal damage associated with the use of nonsteroidal antiinflammatory drugs. N Engl J Med. 1992 Sep 10;327(11):749-54. doi: 10.1056/NEJM199209103271101.
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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 Flurbiprofen in people with Pain, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001724, which also lists 3 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 4 Mar 2008.