Trial to Evaluate the Efficacy on Local Anesthesia and Safety of 2% Lidocaine HCl With Different Epinephrine Concentration in Patients Undergoing Surgical Extraction of Impacted Lower Third Molars

NCT02696369 | Completed Phase 4

• 1 other identifier: HU-015
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study is Phase 4 trial which evaluates the safety and efficacy of 2% Lidocaine HCl with different epinephrine concentration in patients undergoing surgical extraction of impacted lower third molars

Conditions

Third Molar

Outcome Measures

Primary Outcomes (1)

• Pain visual analogue scale (VAS)

  To acess the pain immediately after the surgical extraction of impacted lower third molars

  Immediately after the extraction

Secondary Outcomes (8)

• Onset time of anesthesia

  Immediately after administration of IP

• Local anesthetic duration

  Immediately after onset of anesthesia

• Pain VAS

  2, 4, 6 hours after administration of the investigational product (IP)

• Onset time of pain after administration of IP

  Immediately after injection

• Bleeding after extraction measured by the operator

  Immediately after extraction

Study Arms (2)

2% Lidocaine HCL:Epinephrine inj.

EXPERIMENTAL

2% Lidocaine HCL with epinephrine 1:200,000

Drug: 2% lidocaine HCl with epinephrine 1:200,000

2% Lidocaine HCL:Epinephrine inj. (3M)

ACTIVE COMPARATOR

2% Lidocaine HCl with epinephrine 1:80,000

Drug: 2% lidocaine HCl with epinephrine 1:80,000

Interventions

2% lidocaine HCl with epinephrine 1:200,000 DRUG

2% Lidocaine HCL:Epinephrine inj.

2% lidocaine HCl with epinephrine 1:80,000 DRUG

2% Lidocaine HCL:Epinephrine inj. (3M)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 19
• Physical grade 1 or 2 by American Society of Anesthesiologists (ASA)
• Mesioangular or horizontal angulation categorized by winter classification

You may not qualify if:

• Allergy or hypersensitivity about the investigated products
• Any infection or edema during the extraction
• The following patients: clotting disorder, hyperthyroidism, arteriosclerosis, cardiac insufficiency, other cardiovascular disorders
• Pregnancy or breast-feeding
• Any conditions that the investigator considers not to appropriate for this study

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Huons

Ansan, Kyeonggi-do, 426791, South Korea

Location

MeSH Terms

Interventions

Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 2, 2016
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

KR (1)