Unique ID issued by UMIN | UMIN000034631 |
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Receipt number | R000039325 |
Scientific Title | Phase II trial of articaine hydrochloride with adrenaline bitartrate in dental patients |
Date of disclosure of the study information | 2018/10/24 |
Last modified on | 2024/01/18 11:08:37 |
Phase II trial of articaine hydrochloride with adrenaline bitartrate in dental patients
Phase II trial of articaine
Phase II trial of articaine hydrochloride with adrenaline bitartrate in dental patients
Phase II trial of articaine
Japan |
Dental disease
Dental medicine |
Others
NO
To evaluate the clinical safety and efficacy of a single use of articaine hydrochloride with adrenaline bitartrate as infiltration anesthesia for dental treatment or local anesthesia for oral surgery (infiltration anesthesia or the combination infiltration and conduction anesthesia) in adult Japanese.
Safety,Efficacy
Phase II
VAS (visual analog scale) during dental procedures after the investigational new drug injection (evaluated by patients)
1) VAS during dental procedures after the investigational new drug injection (evaluated by dental practitioners)
2) The category evaluation based on VAS (evaluated by patients and dental practitioners) during dental procedures after the investigational new drug injection.(Category classification: [0.0-1.2, 1.3-2.0 (mild pain), 2.1-7.9, 8.0 (severe pain)-10.0])
3) VAS during the investigational new drug injection (evaluated by patients)
4) The duration of local anesthesia effect after the investigational new drug injection (evaluated by patients)
5) Accomplishment of dental procedures using the investigational new drug (presence or absence of other local anesthetics using from the start to the end of dental procedures)
6) Dosage amount (total dose, initial dose)
7) Duration of dental procedure
8) VAS during dental procedure which had warranted the additional administration (evaluated by dental practitioners)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Dental local anesthesia using articaine.
Single use of the articaine hydrochloride of the following dose as the infiltration anesthesia or local anesthesia (the combination of infiltration and conduction anesthesia) by the submucosally injection in oral cavity.
Infiltration anesthesia: 0.5-5.1mL (20-204mg articaine hydrochloride)
Conduction anesthesia: 0.5-3.4mL (20-136mg articaine hydrochloride)
Local anesthesia for oral surgery: 1.0-5.1mL (40-204mg articaine hydrochloride)
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Japanese patients (outpatients or inpatients) whose age is from 20 to 80 years old
2) Patients who are scheduled to undergo dental treatments (gingival flap resection of single tooth for removing dental caries, scaling of single tooth, periodontal curettage of single tooth, fixing dental cavity at single tooth, tooth preparation for single crown, pulpectomy of single tooth, fixing dental cavities at multiple teeth, teeth preparations for multiple crowns or pulpectomies of multiple teeth) or oral surgery (single tooth extraction with/without the crown division and removal of alveolar bone, multiple teeth extractions with/without crown division and removal of alveolar bone, extraction of half-impacted or impacted tooth)
3) Patients who have written the informed consent about this clinical trial before participating.
1) Extraction of complete impacted wisdom tooth or maxillofacial surgery
2) Patients with the history of allergy to the composition of this investigational new drug, amide type local anesthetic, adrenaline bitartrate or sodium metabisulfite
3) Patients with hypertension whose systolic blood pressure or diastolic blood pressure is over 180 mmHg or 110 mmHg, respectively.
4) Patients with symptom of arteriosclerosis or patients with unstable coronary artery disease.
5) Patients with cardiac failure whose Metabolic Equivalents (MET) are under 4
6) Hyperthyroidism patients with the symptom of it
7) Patients with uncontrolled diabetes mellitus
8) Patients with severe medical diseases (hepatic disorder, renal disorder, cardiovascular diseases, endocrine system diseases, respiratory diseases etc.) or patients with severe psychiatric diseases.
9) Patients in pregnancy or the possibility of pregnancy. Breast-feeding patients.
10) Patients who received another investigational new drug within 12 weeks before this investigational new drug
11) Patients who have received or is receiving the following medicines or treatment which influence to the pain evaluation within 1week.
・ Opioid analgesics such as morphine, pentazocine etc.
・ Non-steroidal anti-inflammatory drugs such as loxoprofen sodium, aspirin, etc., or antipyretic analgesics such as acetaminophen etc. (exclude the local application)
・ Dental procedures
12) Patients with HIV antibody positivity, HBs antigen positivity or HCV antibody positivity.
13) Patients who are determined as inadequacy by the principal investigator or subinvestigater.
55
1st name | Takuya |
Middle name | |
Last name | Miyawaki |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Dental Anesthesiology and Special Care Dentistry
7008525
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
086-235-6721
miyawaki@md.okayama-u.ac.jp
1st name | Takuya |
Middle name | |
Last name | Miyawaki |
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Dental Anesthesiology and Special Care Dentistry
7008525
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
086-235-6721
miyawaki@md.okayama-u.ac.jp
Okayama University
SHOWA YAKUHIN KAKO CO., LTD
Profit organization
Okayama University Hospital Institutional Review Board
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
086-235-7534
chiken@okayama-u.ac.jp
NO
岡山大学病院(岡山県)、北海道大学病院(北海道)、東京医科歯科大学歯学部附属病院(東京都)、昭和大学歯科病院(東京都)、大阪大学歯学部附属病院(大阪府)、香川大学医学部附属病院(香川県)、徳島大学病院(徳島県)、長崎大学病院(長崎県)、国立病院機構岡山医療センター (岡山県)、倉敷中央病院(岡山県)、山口大学医学部附属病院(山口県)
2018 | Year | 10 | Month | 24 | Day |
https://www.jstage.jst.go.jp/article/jjdsa/52/1/52_26/_article/-char/ja
Published
https://www.jstage.jst.go.jp/article/jjdsa/52/1/52_26/_article/-char/ja
55
The total dose of articaine (mean( SD)) was 2.408(1.343) mL.
The mean (two-sided 95% CI) VAS (evaluated by patients) during dental procedures after articaine administration (primary endpoint) was 0.65 (0.27-1.02), statistically significantly below the efficacy criterion of 1.3 (p = 0.0005).
The percentages of subjects with VAS (patient-evaluated) between 0.0 and 1.2 were 84.9%, and the percentages of subjects with VAS less than 2.0 were 90.6%. None of the subjects had severe pain (over VAS 8.0).
2024 | Year | 01 | Month | 18 | Day |
Delay expected |
We refrain from publishing the results because a phase III trial is in progress.
2024 | Year | 01 | Month | 15 | Day |
Males accounted for 50.9% (27/53) and females 49.1% (26/53). Age (mean(SD)) and weight were 40.9(18.1) years and 61.08(13.77) kg, respectively.
Of the 55 patients who received articaine, one patient each of investigational drug administration violation and eligibility criteria violation was excluded.
During the study period (from the date of study drug administration to 7 days after study drug administration), there were 8 adverse events in 5 patients (swelling, wound pain, subcutaneous hemorrhage, trismus, dry socket, abnormal perception, hypoesthesia of tongue and stomatitis). One adverse event (adverse drug reaction), " hypoesthesia of tongue," was not ruled out as causally related to the study drug. All patients recovered.
Primary outcome
VAS (visual analog scale) during dental procedures after the investigational new drug injection (evaluated by patients).
Secondary outcome
1) VAS during dental procedures after the investigational new drug injection (evaluated by dental practitioners).
2) The category evaluation based on VAS (evaluated by patients and dental practitioners) during dental procedures after the investigational new drug injection. (Category classification: [0.0-1.2, 1.3-2.0 (mild pain), 2.1-7.9, 8.0 (severe pain)-10.0]).
3) VAS during the investigational new drug injection (evaluated by patients).
4) The duration of local anesthesia effect after the investigational new drug injection (evaluated by patients).
5) Accomplishment of dental procedures using the investigational new drug (presence or absence of other local anesthetics using from the start to the end of dental procedures).
6) Dosage amount (total dose, initial dose).
7) Duration of dental procedure.
8) VAS during dental procedure which had warranted the additional administration (evaluated by dental practitioners).
Completed
2018 | Year | 08 | Month | 21 | Day |
2018 | Year | 07 | Month | 24 | Day |
2018 | Year | 12 | Month | 26 | Day |
2019 | Year | 09 | Month | 24 | Day |
2020 | Year | 03 | Month | 06 | Day |
2020 | Year | 03 | Month | 06 | Day |
2018 | Year | 10 | Month | 24 | Day |
2024 | Year | 01 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039325
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