PainPhase 2NCT01062113
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
A Phase 2 study testing Celecoxib in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.
Trial summary
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Pain
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 22 sitesJapan
- Study dates
- Apr 2010to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Initial dose:
- 20 to 64 years
- Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting
- Patients with pain that meets both of the following criteria
- Pain intensity (4-categorical): "moderate pain" or "severe pain"
- Pain intensity (VAS): 45.0 mm or more
- Additional dose:
- Patients with pain that corresponds to "4. Agree" or "5. Strongly agree" as the answer to the "question about the pain intensity" during the period from 5 hours to 12 hours post-initial dose of the study drug
Who cannot join
- Patients with acute inflammatory findings in the oral cavity necessitating treatment
- Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Tokai University Hachioji Hospital
Hachiouji-shi, Tokyo
Tokai University Hospital
Isehara-shi, Kanagawa
Kanazawa Medical Center
Kanazawa, Ishikawa-ken
Kagawa University Faculty of Medicine University Hospital
Kita-gun, Kagawa-ken
Kyushu Dental College Hospital
Kitakyusyu-shi, Fukuoka
Kumamoto Medical Center
Kumamoto, Kumamoto
Kure Kyosai Hospital
Kure-shi, Hiroshima
Japan Red Cross Musashino Hospital
Musashino-shi, Tokyo
The Nippon Dental University Niigata Hospital
Niigata, Niigata
Jyuzen General Hospital
Niihama-shi, Ehime
Osaka Dental University Hospital
Osaka, Osaka
Osaka Prefectural General Medical Center
Osaka, Osaka
Showa University Dental Hospital
Ōta-ku, Tokyo
Meikai University Hospital
Sakado-shi, Saitama
Sendai Medical Center
Sendai, Miyagi
Kanto Medical Center NTT EC
Shinagawa-ku, Tokyo
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo
Shizuoka Medical Center
Sunto-gun, Shizuoka
Bishinkai Medical Corporation Health Park Clinic
Takasaki-shi, Gunma
Maruko Central General Hospital
Ueda-shi, Nagano
Nagano National Hospital
Ueda-shi, Nagano
Tochigi National Hospital
Utsunomiya, Tochigi
About this study
Official title: A Randomized, Double-Blind, Multicenter, Comparative Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In The Treatment Of Acute Pain After Oral Surgery Lateral Mandibular Impacted Third Molar Tooth Extraction
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Initial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS
CelecoxibDrug
Additional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
PlaceboDrug
Additional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib 400mg | Experimental | Not described Receives: Drug: Celecoxib |
| Celecoxib 200mg | Experimental | Not described Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Rate (Percentage) of Patient's Impression
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor".
Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
Measured: 2 hours post-additional dose
Secondary outcomes (3)
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Pain intensity was entered in the patient diary on the following categories: "No pain", "Mild pain", "Moderate pain" and "Severe pain".
Measured: 2 hours after additional dose
Pain Intensity Measured by Visual Analog Scale (VAS)
The Pain intensity was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=unbearable maximal pain.
Measured: 2 hours post-additional dose
Differences in Pain Intensity (PI) Measured by VAS Among Participants
The differences in PI were obtained by subtracting the PI at each time point from the Baseline PI score.
Measured: Pre-additional dose (baseline) and 2 hours post-additional dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062113
- Sponsor's protocol ID
- A3191200
- Status last verified
- Jan 2021
- First submitted
- 2 Feb 2010
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan. Clin Ther. 2012 Feb;34(2):314-28. doi: 10.1016/j.clinthera.2012.01.004. Epub 2012 Jan 28.
PubMed 22284900
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Comparative Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In The Treatment Of Acute Pain After Oral Surgery Lateral Mandibular Impacted Third Molar Tooth Extraction
- ClinicalTrials.gov ID
- NCT01062113
- Acronym / sponsor ID
- A3191200
- Conditions
- Pain
- Keywords
- Acute pain after oral surgery lateral mandibular Impacted third molar tooth extraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 19 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celecoxib 400mg | Experimental | Drug: Celecoxib |
| Celecoxib 200mg | Experimental | Drug: Celecoxib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 20 to 64 years
- Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting
- Patients with pain that meets both of the following criteria
- Pain intensity (4-categorical): "moderate pain" or "severe pain"
- Pain intensity (VAS): 45.0 mm or more
Key exclusion criteria (2 listed)
- Patients with acute inflammatory findings in the oral cavity necessitating treatment
- Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
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 |
|---|---|---|
| CelecoxibInitial dose: Celecoxib 200mg tablet x 2 will be administrated during a period from 1 to 2 hours post lateral mandibular impacted third molar tooth extraction in subjects with "moderate pain" or "severe pain"rated as 45.0 mm or more on the VAS | Drug | Celecoxib 400mg |
| CelecoxibAdditional dose: Celecoxib 200mg tablet x 1 will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain | Drug | Celecoxib 200mg |
| PlaceboAdditional dose: Placebo (tablet) will be administrated during a period from 5 to 12 hours post-initial dose of Celecoxib 400mg in subjects who require an additional analgesic dose for any pain | Drug | Placebo |
Primary outcome
Efficacy Rate (Percentage) of Patient's Impression
Time frame: 2 hours post-additional dose
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor". Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
3 secondary outcomes
Number of Participants in Each Pain Intensity (PI) With 4 Categories
Time frame: 2 hours after additional dose
Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: 2 hours post-additional dose
Differences in Pain Intensity (PI) Measured by VAS Among Participants
Time frame: Pre-additional dose (baseline) and 2 hours post-additional dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22284900Saito K, Kaneko A, Machii K, Ohta H, Ohkura M, Suzuki M. Efficacy and safety of additional 200-mg dose of celecoxib in adult patients with postoperative pain following extraction of impacted third mandibular molar: a multicenter, randomized, double-blind, placebo-controlled, phase II study in Japan. Clin Ther. 2012 Feb;34(2):314-28. doi: 10.1016/j.clinthera.2012.01.004. Epub 2012 Jan 28.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 22 sites in Japan.
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 2 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. 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 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?
Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy Rate (Percentage) of Patient's Impression (time frame: 2 hours post-additional dose). 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 NCT01062113, 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 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.