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Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Colorado
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Fort Collins, Colorado, Verenigde Staten, 80525
- Big Grins
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.
- Normal lip, nose, eyelid, and cheek sensation.
- Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- If age 8 and above, able to understand and provide informed assent.
- Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
- Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).
Exclusion Criteria:
- Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.
- History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
- Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
- Inadequately controlled thyroid disease of any type.
- Use of any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- Frequent nose bleeds (≥ 5 per month).
- Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
- History of congenital or idiopathic methemoglobinemia.
- Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
- History of alcoholism and/or drug abuse.
- Pulpal pathology in the index tooth.
- Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.
- Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome.
- Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug administration.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Kovacaine Mist High Dose
400uL of Kovacaine Mist, as 2 sprays of 200uL.
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2 unilateral intranasal sprays of 200uL each.
Andere namen:
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Experimenteel: Kovacaine Mist Mid Dose
200uL of Kovacaine Mist, as 2 sprays of 100uL.
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2 unilateral intranasal sprays of 100uL each.
Andere namen:
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Experimenteel: Kovacaine Mist Low Dose
120uL of Kovacaine Mist, as 2 sprays of 60uL.
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2 unilateral intranasal sprays of 60uL each.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
Tijdsspanne: at 14 minutes with a 3 minute window
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If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
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at 14 minutes with a 3 minute window
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Naris Examination (NE) to Assess Reactions to the Study Drug.
Tijdsspanne: At Baseline and 120 Minutes
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The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
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At Baseline and 120 Minutes
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Systolic Blood Pressure
Tijdsspanne: At Baseline, 12 minutes, and 120 minutes
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At Baseline, 12 minutes, and 120 minutes
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Diastolic Blood Pressure
Tijdsspanne: At Baseline, 12 minutes, and 120 minutes
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At Baseline, 12 minutes, and 120 minutes
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Heart Rate
Tijdsspanne: At Baseline, 12 minutes, and 120 minutes
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At Baseline, 12 minutes, and 120 minutes
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Oxygen Saturation
Tijdsspanne: At Baseline, 12 minutes, and 120 minutes
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At Baseline, 12 minutes, and 120 minutes
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Number of Participants With Adverse Events by Dose Level and Age
Tijdsspanne: from baseline to 24 hours following drug administration
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from baseline to 24 hours following drug administration
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Incidence of Adverse Events by Dose Level Regardless of Age
Tijdsspanne: from baseline to 24 hours following drug administration
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from baseline to 24 hours following drug administration
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Fysiologische effecten van medicijnen
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Depressiva van het centrale zenuwstelsel
- Autonome agenten
- Agenten van het perifere zenuwstelsel
- Sensorische systeemagenten
- Anesthesie
- Beschermende middelen
- Adrenerge alfa-agonisten
- Adrenerge agonisten
- Cardiotone middelen
- Anesthesie, lokaal
- Agenten van het ademhalingssysteem
- Sympathicomimetica
- Vasoconstrictieve middelen
- Mydriatica
- Nasale decongestiva
- Adrenerge alfa-1-receptoragonisten
- Fenylefrine
- Oxymetazoline
- Tetracaïne
Andere studie-ID-nummers
- SR 2-03
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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