UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034631
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Okayama University

Institute

Department

Personal name



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

https://www.jstage.jst.go.jp/article/jjdsa/52/1/52_26/_article/-char/ja

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jjdsa/52/1/52_26/_article/-char/ja

Number of participants that the trial has enrolled

55

Results

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).

Results date posted

2024 Year 01 Month 18 Day

Results Delayed

Delay expected

Results Delay Reason

We refrain from publishing the results because a phase III trial is in progress.

Date of the first journal publication of results

2024 Year 01 Month 15 Day

Baseline Characteristics

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.

Participant flow

Of the 55 patients who received articaine, one patient each of investigational drug administration violation and eligibility criteria violation was excluded.

Adverse events

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.

Outcome measures

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).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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 12 Month 26 Day

Last follow-up date

2019 Year 09 Month 24 Day

Date of closure to data entry


Date trial data considered complete

2020 Year 03 Month 06 Day

Date analysis concluded

2020 Year 03 Month 06 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 24 Day

Last modified on

2024 Year 01 Month 18 Day



Link to view the page

Value
https://center6.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