- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01701505
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Colorado
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Fort Collins, Colorado, Förenta staterna, 80525
- Big Grins
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Kovacaine Mist High Dose
400uL of Kovacaine Mist, as 2 sprays of 200uL.
|
2 unilateral intranasal sprays of 200uL each.
Andra namn:
|
Experimentell: Kovacaine Mist Mid Dose
200uL of Kovacaine Mist, as 2 sprays of 100uL.
|
2 unilateral intranasal sprays of 100uL each.
Andra namn:
|
Experimentell: Kovacaine Mist Low Dose
120uL of Kovacaine Mist, as 2 sprays of 60uL.
|
2 unilateral intranasal sprays of 60uL each.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
Tidsram: at 14 minutes with a 3 minute window
|
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.
|
at 14 minutes with a 3 minute window
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Naris Examination (NE) to Assess Reactions to the Study Drug.
Tidsram: At Baseline and 120 Minutes
|
The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
|
At Baseline and 120 Minutes
|
Systolic Blood Pressure
Tidsram: At Baseline, 12 minutes, and 120 minutes
|
At Baseline, 12 minutes, and 120 minutes
|
|
Diastolic Blood Pressure
Tidsram: At Baseline, 12 minutes, and 120 minutes
|
At Baseline, 12 minutes, and 120 minutes
|
|
Heart Rate
Tidsram: At Baseline, 12 minutes, and 120 minutes
|
At Baseline, 12 minutes, and 120 minutes
|
|
Oxygen Saturation
Tidsram: At Baseline, 12 minutes, and 120 minutes
|
At Baseline, 12 minutes, and 120 minutes
|
|
Number of Participants With Adverse Events by Dose Level and Age
Tidsram: from baseline to 24 hours following drug administration
|
from baseline to 24 hours following drug administration
|
|
Incidence of Adverse Events by Dose Level Regardless of Age
Tidsram: from baseline to 24 hours following drug administration
|
from baseline to 24 hours following drug administration
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Depressiva medel i centrala nervsystemet
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Sensoriska systemagenter
- Bedövningsmedel
- Skyddsmedel
- Adrenerga alfa-agonister
- Adrenerga agonister
- Kardiotoniska medel
- Anestesimedel, lokal
- Andningsorgan
- Sympatomimetika
- Vasokonstriktormedel
- Mydriatics
- Nasala avsvällande medel
- Adrenerga alfa-1-receptoragonister
- Fenylefrin
- Oxymetazolin
- Tetrakain
Andra studie-ID-nummer
- SR 2-03
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på 400uL of Kovacaine Mist
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Celleration, Inc.AvslutadHudens sårFörenta staterna
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Celleration, Inc.AvslutadDiabetisk fotsårFörenta staterna
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Georgetown UniversityCelleration, Inc.Indragen