PainPhase 2NCT00026819
Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction
A Phase 2 study testing Rofecoxib 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 ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Rofecoxib
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Nov 2003
- 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
Who may be able to join
- Male or female volunteers referred for third molar extraction willing to undergo 3 visits: 1 screening visit, 1 surgical appointment, and 1 follow-up research-related 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 four hours post-operatively
- Willing to complete a 100 mm visual analog scale and a category scale every hour for the first 4 post-operative hours, and again at 24 and 48 hours
- Willing to have a preoperative biopsy on the day of surgery and a postoperative biopsy at 48 hours
- Willing to return 48 hours to return completed pain diaries and for the postoperative biopsy
- Sum total of the assessment of surgical difficulty ratings (Screening visit) must be between 8 to 14 in order to evaluate subjects experiencing similar pain levels.
Who cannot join
- Allergy to aspirin or NSAIDS
- Pregnant or lactating females
- History of peptic ulcers and GI bleeding
- Chronic use of medications confounding the assessment of the inflammatory response or analgesia ( antihistamines, NSAIDS, steroids, antidepressants, sulfa drugs)
- Presence of a clinical signs suggestive of infection or inflammation
- Unusual surgical difficulty
- Surgical difficulty assessment rating less than 8 or greater than 14
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: Pre-Emptive Analgesic Effects of a Selective COX-2 Inhibitor (Rofecoxib) in the Oral Surgery Model
This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain.
Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal.
Read more
Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein.
After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed.
Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
Read the detailed description
Pain and inflammation are predictable sequelae following tissue injury, such as surgery. Conventional treatment for intraoperative and postoperative control of pain includes local anesthetic administered preoperatively and analgesics administered postoperatively. Disadvantages of these approaches include pain during the interval when the effect of local anesthesia dissipates and the postoperatively administered analgesic takes effect and adverse effects of opioid-containing analgesics in ambulatory patients. Research over the past two decades has demonstrated that administering nonsteroidal anti-inflammatory drugs (NSAIDs) preoperatively significantly reduces the intensity and the duration of postoperative pain up to eight hours (Dionne et al., 1978 and Jackson et al., 1989). Parallel clinical investigations suggest that the pre-emptive treatment with a long-acting local anesthetic or an NMDA-antagonist reduces pain at 24 to 72 hours post-surgery (Gordon et al., 1997; Yamamoto et al., 1993; Gordon et al., 1999). This proposed clinical trial will use the oral surgery model to assess the therapeutic efficacy of pre-emptive and preventive treatment with a potent selective COX-2 inhibitor, rofecoxib (Vioxx® (Registered Trademark)), given prior to and following third molar extractions to reduce postoperative pain at 24 and 48 hours post-surgery.
This study is a double-blind, randomized control trial with parallel groups using placebo, ibuprofen, or rofecoxib. Rofecoxib 50 mg will be administered PO 90 minutes before surgery in the Clinical Center at NIH and another 50 mg will be self-administered 24 hours later by the subjects at their homes. This regimen is predicted to suppress the onset and intensity of post-operative dental pain to a greater extent than placebo or a non-selective COX-1/COX-2 inhibitor (ibuprofen). The analgesic effect of the drugs will be estimated by hourly observations over the first four hours after surgery using two different measures of pain intensity, the category scale and a visual analog scale (VAS). It is hypothesized that the pre-emptive administration of a selective COX-2 inhibitor, rofecoxib will inhibit the development of central and peripheral sensitization following tissue injury which manifests as hyperalgesia at later time points.
- Conditions
- Pain
- Being tested
- Rofecoxib
- Keywords
- NSAID, Acute Pain Model, Hyperalgesia, Central Sensitization, Wisdom Teeth, Wisdom Teeth Extraction, Third Molar
- Medical subject headings
- Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RofecoxibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startNov 2001
- Study completionNov 2003
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
- 150 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
- NCT00026819
- Sponsor's protocol ID
- 020046
- Other IDs
- 02-D-0046
- Status last verified
- Nov 2003
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000 Nov 23;343(21):1520-8, 2 p following 1528. doi: 10.1056/NEJM200011233432103.
PubMed 11087881Dionne RA, Campbell RA, Cooper SA, Hall DL, Buckingham B. Suppression of postoperative pain by preoperative administration of ibuprofen in comparison to placebo, acetaminophen, and acetaminophen plus codeine. J Clin Pharmacol. 1983 Jan;23(1):37-43. doi: 10.1002/j.1552-4604.1983.tb02702.x.
PubMed 6341415Bannwarth B, Netter P, Pourel J, Royer RJ, Gaucher A. Clinical pharmacokinetics of nonsteroidal anti-inflammatory drugs in the cerebrospinal fluid. Biomed Pharmacother. 1989;43(2):121-6. doi: 10.1016/0753-3322(89)90140-6.
PubMed 2660917
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
- Pre-Emptive Analgesic Effects of a Selective COX-2 Inhibitor (Rofecoxib) in the Oral Surgery Model
- ClinicalTrials.gov ID
- NCT00026819
- Acronym / sponsor ID
- 020046
- Conditions
- Pain
- Keywords
- NSAID, Acute Pain Model, Hyperalgesia, Central Sensitization, Wisdom Teeth, Wisdom Teeth Extraction, Third Molar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Nov 2001
- Study completion
- Nov 2003
- First posted
- 15 Nov 2001 (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 ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain.
Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal.
Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein.
After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed.
Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
Detailed description
Pain and inflammation are predictable sequelae following tissue injury, such as surgery. Conventional treatment for intraoperative and postoperative control of pain includes local anesthetic administered preoperatively and analgesics administered postoperatively. Disadvantages of these approaches include pain during the interval when the effect of local anesthesia dissipates and the postoperatively administered analgesic takes effect and adverse effects of opioid-containing analgesics in ambulatory patients. Research over the past two decades has demonstrated that administering nonsteroidal anti-inflammatory drugs (NSAIDs) preoperatively significantly reduces the intensity and the duration of postoperative pain up to eight hours (Dionne et al., 1978 and Jackson et al., 1989). Parallel clinical investigations suggest that the pre-emptive treatment with a long-acting local anesthetic or an NMDA-antagonist reduces pain at 24 to 72 hours post-surgery (Gordon et al., 1997; Yamamoto et al., 1993; Gordon et al., 1999). This proposed clinical trial will use the oral surgery model to assess the therapeutic efficacy of pre-emptive and preventive treatment with a potent selective COX-2 inhibitor, rofecoxib (Vioxx® (Registered Trademark)), given prior to and following third molar extractions to reduce postoperative pain at 24 and 48 hours post-surgery.
This study is a double-blind, randomized control trial with parallel groups using placebo, ibuprofen, or rofecoxib. Rofecoxib 50 mg will be administered PO 90 minutes before surgery in the Clinical Center at NIH and another 50 mg will be self-administered 24 hours later by the subjects at their homes. This regimen is predicted to suppress the onset and intensity of post-operative dental pain to a greater extent than placebo or a non-selective COX-1/COX-2 inhibitor (ibuprofen). The analgesic effect of the drugs will be estimated by hourly observations over the first four hours after surgery using two different measures of pain intensity, the category scale and a visual analog scale (VAS). It is hypothesized that the pre-emptive administration of a selective COX-2 inhibitor, rofecoxib will inhibit the development of central and peripheral sensitization following tissue injury which manifests as hyperalgesia at later time points.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female volunteers referred for third molar extraction willing to undergo 3 visits: 1 screening visit, 1 surgical appointment, and 1 follow-up research-related 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 four hours post-operatively
- Willing to complete a 100 mm visual analog scale and a category scale every hour for the first 4 post-operative hours, and again at 24 and 48 hours
Key exclusion criteria (7 listed)
- Allergy to aspirin or NSAIDS
- Pregnant or lactating females
- History of peptic ulcers and GI bleeding
- Chronic use of medications confounding the assessment of the inflammatory response or analgesia ( antihistamines, NSAIDS, steroids, antidepressants, sulfa drugs)
- Presence of a clinical signs suggestive of infection or inflammation
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 |
|---|---|---|
| Rofecoxib | 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 11087881Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000 Nov 23;343(21):1520-8, 2 p following 1528. doi: 10.1056/NEJM200011233432103.
- Background: PubMed 6341415Dionne RA, Campbell RA, Cooper SA, Hall DL, Buckingham B. Suppression of postoperative pain by preoperative administration of ibuprofen in comparison to placebo, acetaminophen, and acetaminophen plus codeine. J Clin Pharmacol. 1983 Jan;23(1):37-43. doi: 10.1002/j.1552-4604.1983.tb02702.x.
- Background: PubMed 2660917Bannwarth B, Netter P, Pourel J, Royer RJ, Gaucher A. Clinical pharmacokinetics of nonsteroidal anti-inflammatory drugs in the cerebrospinal fluid. Biomed Pharmacother. 1989;43(2):121-6. doi: 10.1016/0753-3322(89)90140-6.
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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 Rofecoxib 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.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 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 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 NCT00026819, 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.