Pain Clinical Trial
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
NCT number | NCT01062113 |
Other study ID # | A3191200 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2010 |
Est. completion date | August 2010 |
Verified date | January 2021 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 255 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 64 Years |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Tokai University Hachioji Hospital | Hachiouji-shi | Tokyo |
Japan | Tokai University Hospital | Isehara-shi | Kanagawa |
Japan | Kanazawa Medical Center | Kanazawa-shi | Ishikawa |
Japan | Kagawa University Faculty of Medicine University Hospital | Kita-gun | Kagawa |
Japan | Kyushu Dental College Hospital | Kitakyusyu-shi | Fukuoka |
Japan | Kumamoto Medical Center | Kumamoto-shi | Kumamoto |
Japan | Kure Kyosai Hospital | Kure-shi | Hiroshima |
Japan | Japan Red Cross Musashino Hospital | Musashino-shi | Tokyo |
Japan | The Nippon Dental University Niigata Hospital | Niigata-shi | Niigata |
Japan | Jyuzen General Hospital | Niihama-shi | Ehime |
Japan | Osaka Dental University Hospital | Osaka-shi | Osaka |
Japan | Osaka Prefectural General Medical Center | Osaka-shi | Osaka |
Japan | Showa University Dental Hospital | Ota-ku | Tokyo |
Japan | Meikai University Hospital | Sakado-shi | Saitama |
Japan | Sendai Medical Center | Sendai-shi | Miyagi |
Japan | Kanto Medical Center NTT EC | Shinagawa-ku | Tokyo |
Japan | Tokyo Medical University Hospital | Shinjuku-ku | Tokyo |
Japan | Shizuoka Medical Center | Sunto-gun | Shizuoka |
Japan | Bishinkai Medical Corporation Health Park Clinic | Takasaki-shi | Gunma |
Japan | Maruko Central General Hospital | Ueda-shi | Nagano |
Japan | Nagano National Hospital | Ueda-shi | Nagano |
Japan | Tochigi National Hospital | Utsunomiya-shi | Tochigi |
Lead Sponsor | Collaborator |
---|---|
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
2 hours post-additional dose | |
Secondary | 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". | 2 hours after additional dose | |
Secondary | 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. | 2 hours post-additional dose | |
Secondary | 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. | Pre-additional dose (baseline) and 2 hours post-additional dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Terminated |
NCT04356352 -
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04466111 -
Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
|
||
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05868122 -
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
|
Phase 3 | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Enrolling by invitation |
NCT06087432 -
Is PNF Application Effective on Temporomandibular Dysfunction
|
N/A | |
Completed |
NCT05508594 -
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
|
Phase 2/Phase 3 | |
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Completed |
NCT02913027 -
Can We Improve the Comfort of Pelvic Exams?
|
N/A | |
Terminated |
NCT02181387 -
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
|
Phase 4 | |
Recruiting |
NCT06032559 -
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
|
Phase 3 | |
Active, not recruiting |
NCT03613155 -
Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care
|