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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034631
Receipt No. 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 2019/05/08

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Basic information
Public title Phase II trial of articaine hydrochloride with adrenaline bitartrate in dental patients
Acronym Phase II trial of articaine
Scientific Title Phase II trial of articaine hydrochloride with adrenaline bitartrate in dental patients
Scientific Title:Acronym Phase II trial of articaine
Region
Japan

Condition
Condition Dental disease
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes VAS (visual analog scale) during dental procedures after the investigational new drug injection (evaluated by patients)
Key secondary outcomes 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)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name Takuya
Middle name
Last name Miyawaki
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Dental Anesthesiology and Special Care Dentistry
Zip code 7008525
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6721
Email miyawaki@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Miyawaki
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Dental Anesthesiology and Special Care Dentistry
Zip code 7008525
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6721
Homepage URL
Email miyawaki@md.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization SHOWA YAKUHIN KAKO CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Hospital Institutional Review Board
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel 086-235-7534
Email chiken@okayama-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 21 Day
Date of IRB
2018 Year 07 Month 24 Day
Anticipated trial start date
2018 Year 10 Month 24 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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